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Medical Network News, August 25.
In recent years, the national policy to encourage drug innovation has continued to increase, and batches of clinically urgently needed drugs have been approved to enter the market
.
According to data obtained by a reporter from the National Food and Drug Administration of the "Pharmaceutical Economic News", 21 Class 1 innovative drugs have been approved for marketing in the first half of 2021.
This number has exceeded the number of 20 innovative drugs approved for the whole year of 2020.
This also means that China has set a new record in the review of innovative drugs
.
In recent years, the national policy to encourage drug innovation has continued to increase, and batches of clinically urgently needed drugs have been approved to enter the market
.
According to data obtained by a reporter from the National Food and Drug Administration of the "Pharmaceutical Economic News", 21 Class 1 innovative drugs have been approved for marketing in the first half of 2021.
This number has exceeded the number of 20 innovative drugs approved for the whole year of 2020.
This also means that China has set a new record in the review of innovative drugs
.
From the perspective of the treatment field, these products mainly involve the prevention and treatment drugs needed for emergency public health emergencies, and urgently needed clinical drugs such as tumors, rare diseases and immune system diseases, many of which are independently developed by China and have independent intellectual property rights
.
.
As we all know, after the outbreak of the new crown pneumonia, the task of special approval for the prevention and treatment of new crown pneumonia is very heavy
.
As of June 30, 4 new crown vaccines have been conditionally approved for marketing, 22 vaccines and 19 therapeutic biological products (including 12 neutralizing antibodies) have been approved for clinical trials through special approval procedures; "Tripartite" related Chinese medicine varieties (Qingfei Paidu Granules, Huashi Baidu Granules, Xuanfei Baidu Granules) were approved for marketing
.
.
As of June 30, 4 new crown vaccines have been conditionally approved for marketing, 22 vaccines and 19 therapeutic biological products (including 12 neutralizing antibodies) have been approved for clinical trials through special approval procedures; "Tripartite" related Chinese medicine varieties (Qingfei Paidu Granules, Huashi Baidu Granules, Xuanfei Baidu Granules) were approved for marketing
.
Under the tremendous pressure of emergency review of products for the prevention and treatment of new coronary pneumonia, how has the number of innovative drugs approved to break the record? Kong Fanpu, director of the Center for Drug Evaluation of the State Drug Administration, informed that this is inseparable from a series of "combined punches" in the reform of the drug review and approval system in recent years
.
.
He pointed out that in order to meet the innovation needs of the pharmaceutical industry, in July 2020, the Center for Drug Evaluation has opened a number of channels to speed up the listing and registration of drugs
.
This series of approaches is to use limited review resources on innovative drugs and urgently needed drugs with obvious clinical value
.
After recent years of practice and optimization, these reform measures have begun to gradually take effect
.
.
This series of approaches is to use limited review resources on innovative drugs and urgently needed drugs with obvious clinical value
.
After recent years of practice and optimization, these reform measures have begun to gradually take effect
.
Over 90% completed within the time limit
When it comes to the review and approval of Chinese drugs, we have never forgotten the peak time when the backlog reached 22,000
.
Kong Fanpu recalled that when he took up his post at the Drug Evaluation Center at the end of 2018, the relevant policies for the reform of the drug review and approval system had not yet been fully implemented, and the "Drug Registration Management Measures" had not yet adapted to the requirements of the reform of the drug review and approval system.
The bureau leaders also instructed the need to quickly solve the difficult problems in the reform
.
.
Kong Fanpu recalled that when he took up his post at the Drug Evaluation Center at the end of 2018, the relevant policies for the reform of the drug review and approval system had not yet been fully implemented, and the "Drug Registration Management Measures" had not yet adapted to the requirements of the reform of the drug review and approval system.
The bureau leaders also instructed the need to quickly solve the difficult problems in the reform
.
In order to promote the modernization of the drug review system and review capabilities, the Center for Drug Review began to build a drug review process-oriented scientific management system, and divided the entire review work into 8 links according to the process, including task acceptance, task allocation, and professional review , Comprehensive review, communication, expert consultation, written supplement, verification and inspection
.
Each link has set up a research team, and based on the research problems, proposed improvement measures, and gradually applied to the revision of the supporting documents of the "Administrative Measures for Drug Registration"
.
.
Each link has set up a research team, and based on the research problems, proposed improvement measures, and gradually applied to the revision of the supporting documents of the "Administrative Measures for Drug Registration"
.
Incomplete statistics show that in the revision of the supporting documents of the "Administrative Measures for Drug Registration," 30 were completed by the Center for Drug Evaluation
.
.
"Since then, we have improved the review quality and review efficiency by revising supporting documents and drafting guidelines
.
" Kong Fanpu said that the most impressive thing is the opening and optimization of four drug registration procedures: breakthrough treatment, conditional approval, priority review and approval, and special approval
.
In order to use the limited review resources on innovative drugs and urgently needed drugs with obvious clinical value, priority reviews have been reduced from the original 18 items to 5 in accordance with clinical urgent needs
.
The special approval has made a breakthrough in the new crown epidemic last year.
Early intervention, continuous tracking, rolling submission, and joint research and review have ensured the rapid development and marketing of new crown vaccines and new crown drugs
.
.
" Kong Fanpu said that the most impressive thing is the opening and optimization of four drug registration procedures: breakthrough treatment, conditional approval, priority review and approval, and special approval
.
In order to use the limited review resources on innovative drugs and urgently needed drugs with obvious clinical value, priority reviews have been reduced from the original 18 items to 5 in accordance with clinical urgent needs
.
The special approval has made a breakthrough in the new crown epidemic last year.
Early intervention, continuous tracking, rolling submission, and joint research and review have ensured the rapid development and marketing of new crown vaccines and new crown drugs
.
Kong Fanpu said that on the basis of summing up the experience of special approval of anti-epidemic products, these methods will be gradually applied to the review of innovative drugs in the future
.
.
According to the data, in the first half of 2021, 5802 registration application tasks were accepted (calculated by acceptance number), a year-on-year increase of 15.
14%; 4,819 cases were closed, a year-on-year increase of 19.
55 percent, and the overall completion rate of completed tasks within the time limit was 98.
22%
.
With the year-on-year increase in the number of drug registration application tasks and the high technical content of the declared varieties, the overall completion rate of the innovative drug-related tasks of the Center for Drug Evaluation exceeded 90% within the time limit
.
14%; 4,819 cases were closed, a year-on-year increase of 19.
55 percent, and the overall completion rate of completed tasks within the time limit was 98.
22%
.
With the year-on-year increase in the number of drug registration application tasks and the high technical content of the declared varieties, the overall completion rate of the innovative drug-related tasks of the Center for Drug Evaluation exceeded 90% within the time limit
.
In recent years, the Center for Drug Evaluation has not forgotten to benchmark against the latest international practices
.
The US FDA’s Prescription Drug Payment Act (PDUFA) allows pharmaceutical companies to pay application fees to help review agencies increase manpower and material resources, but the completion rate of review tasks within the time limit must reach 90%
.
Kong Fanpu said frankly, "We could not achieve this completion rate last year, but in the first half of this year, whether it is innovative drugs or generic drugs, the overall review completion rate has exceeded this level
.
"
.
The US FDA’s Prescription Drug Payment Act (PDUFA) allows pharmaceutical companies to pay application fees to help review agencies increase manpower and material resources, but the completion rate of review tasks within the time limit must reach 90%
.
Kong Fanpu said frankly, "We could not achieve this completion rate last year, but in the first half of this year, whether it is innovative drugs or generic drugs, the overall review completion rate has exceeded this level
.
"
Accelerate the construction of standards
In order to guide enterprises to avoid detours in R&D and effectively shorten the process of new drug R&D, the Center for Drug Evaluation has also made bold attempts in recent years
.
.
In 2020, the Center for Drug Evaluation has drafted 119 technical guidelines and officially issued 71.
On this basis, another 37 will be issued in the first half of 2021
.
There are 102 plans to be formulated for the whole year of 2021, covering multiple fields such as new coronary pneumonia prevention and treatment drugs, traditional Chinese medicines, chemical drugs, biological products, children's medicines, and individual medicines.
All of them have been launched, and 12 of them are being solicited for comments, and public comments have been completed.
Of the 24, 12 have been submitted to the National Bureau for review, and 2 will be released soon after review and approval by the National Bureau
.
On this basis, another 37 will be issued in the first half of 2021
.
There are 102 plans to be formulated for the whole year of 2021, covering multiple fields such as new coronary pneumonia prevention and treatment drugs, traditional Chinese medicines, chemical drugs, biological products, children's medicines, and individual medicines.
All of them have been launched, and 12 of them are being solicited for comments, and public comments have been completed.
Of the 24, 12 have been submitted to the National Bureau for review, and 2 will be released soon after review and approval by the National Bureau
.
Kong Fanpu explained, “Before 2020, we have only 204 drug development technology guidelines.
In the past two years, we have added more than 100, and the total number has exceeded 300.
Next year, this number will increase significantly
.
At present, judging from the number of issued guidelines, the EU has more than 400, and the United States has more than the EU
.
" This also shows that China's drug review system is accelerating on the international track
.
In the past two years, we have added more than 100, and the total number has exceeded 300.
Next year, this number will increase significantly
.
At present, judging from the number of issued guidelines, the EU has more than 400, and the United States has more than the EU
.
" This also shows that China's drug review system is accelerating on the international track
.
In addition, the Center for Drug Evaluation has also continuously explored and issued the "Guiding Principles for Real-World Data for Generating Real-World Evidence (Trial)" to promote the establishment of a real-world research-related guiding principle system that can effectively guide practice
.
.
During the interview, the reporter learned that real-world research plays a key role in supplementing children's medication information
.
Due to the difficulty in implementing children's clinical research, how to use existing research data to support children's drug research and development and clinical rational use is a common problem faced by global regulatory agencies
.
.
Due to the difficulty in implementing children's clinical research, how to use existing research data to support children's drug research and development and clinical rational use is a common problem faced by global regulatory agencies
.
Kong Fanpu said that in the next step, the drug review center will conduct retrospective studies or explore real-world data to support the development of children’s drugs for drugs that have not yet been approved for use in children around the world, but domestic and foreign guidelines have clearly recommended drugs for use in children.
Provide evidence for children's use, support the expansion of indications in the instructions, solve the problem of clinical empirical drug delivery, and eliminate the hidden dangers of children's drug use in the majority of families
.
Provide evidence for children's use, support the expansion of indications in the instructions, solve the problem of clinical empirical drug delivery, and eliminate the hidden dangers of children's drug use in the majority of families
.
In addition, in encouraging innovation in traditional Chinese medicine
.
Kong Fanpu said that the evaluation of traditional Chinese medicine should not only adhere to modern evaluation methods, but also pay attention to the importance of traditional Chinese medicine inheritance
.
Combining the clinical practice of the "three prescriptions" of traditional Chinese medicine in the anti-epidemic, the Center for Drug Evaluation has accelerated the completion of the transformation of anti-epidemic results in accordance with category 3.
2 "other traditional Chinese medicine compound preparations derived from ancient classic prescriptions" for the first time
.
In the next step, the Center for Drug Evaluation will refer to the review experience of the "three prescriptions" related varieties, implement the work requirements for the establishment of an expert review committee for ancient classic Chinese medicine compound preparations, and gradually explore the review work procedures and technical requirements that meet the characteristics of traditional Chinese medicine
.
.
Kong Fanpu said that the evaluation of traditional Chinese medicine should not only adhere to modern evaluation methods, but also pay attention to the importance of traditional Chinese medicine inheritance
.
Combining the clinical practice of the "three prescriptions" of traditional Chinese medicine in the anti-epidemic, the Center for Drug Evaluation has accelerated the completion of the transformation of anti-epidemic results in accordance with category 3.
2 "other traditional Chinese medicine compound preparations derived from ancient classic prescriptions" for the first time
.
In the next step, the Center for Drug Evaluation will refer to the review experience of the "three prescriptions" related varieties, implement the work requirements for the establishment of an expert review committee for ancient classic Chinese medicine compound preparations, and gradually explore the review work procedures and technical requirements that meet the characteristics of traditional Chinese medicine
.
The number of acceptances has risen sharply
It is not difficult to see from the annual review report issued by the Center for Drug Evaluation in recent years that the number of drug acceptances has shown a "straight line" increase: 3779 in 2016, 4837 in 2017, 7336 in 2018, 8082 in 2019, 2020 There are more than 10,000 pieces in the year
.
Incomplete statistics show that during the epidemic, the acceptance volume of the Center for Drug Evaluation increased by 26%
.
.
Incomplete statistics show that during the epidemic, the acceptance volume of the Center for Drug Evaluation increased by 26%
.
"If we continue to do this for a long time, manpower will not be possible
.
" Kong Fanpu said frankly, "From the perspective of the number of acceptances in recent years, we have more supplementary applications than the US FDA.
The FDA's CDER and CBER now have more than 7,000 people.
There are only more than 700 people in the audit center, and there is a serious shortage of manpower
.
The methods and methods we summarized in the reform implementation are difficult to implement due to insufficient manpower
.
For example, we intervened in advance.
In 2016, we only had more than 300 communication applications.
Last year we communicated and communicated.
The number of applications has reached more than 3,000.
Although it is a 10-fold increase, it still cannot meet the needs of corporate communication
.
"
.
" Kong Fanpu said frankly, "From the perspective of the number of acceptances in recent years, we have more supplementary applications than the US FDA.
The FDA's CDER and CBER now have more than 7,000 people.
There are only more than 700 people in the audit center, and there is a serious shortage of manpower
.
The methods and methods we summarized in the reform implementation are difficult to implement due to insufficient manpower
.
For example, we intervened in advance.
In 2016, we only had more than 300 communication applications.
Last year we communicated and communicated.
The number of applications has reached more than 3,000.
Although it is a 10-fold increase, it still cannot meet the needs of corporate communication
.
"
In recent years, the dividends of innovative drugs have been gradually released, and the number of applications accepted has also risen sharply.
The Center for Drug Evaluation has acted as the “helmsman” leading the industry in research and development
.
How to guide the rational development of enterprises?
The Center for Drug Evaluation has acted as the “helmsman” leading the industry in research and development
.
How to guide the rational development of enterprises?
Kong Fanpu said that it is undeniable that while encouraging enterprise innovation, individual fields have also experienced overheating, which is called "pseudo-innovation" by the R&D community
.
The fundamental purpose of drug marketing is to solve the needs of patients, and drug research and development should focus on patient needs and be oriented by clinical value
.
The Center for Drug Evaluation will also pay attention to the guidance in this regard in the formulation and revision of the guidelines, and use the limited R&D resources and review resources to solve urgent clinical needs
.
.
The fundamental purpose of drug marketing is to solve the needs of patients, and drug research and development should focus on patient needs and be oriented by clinical value
.
The Center for Drug Evaluation will also pay attention to the guidance in this regard in the formulation and revision of the guidelines, and use the limited R&D resources and review resources to solve urgent clinical needs
.
At the same time, with regard to the functions of the Yangtze River Delta Sub-center of the Pharmaceutical Industry and the Pharmaceutical Dawan Sub-center, which are more concerned by the industry , Kong Fanpu responded that these two sub-centers are located in the active area of the medical industry.
The audit center merged together to do it
.
At present, the two sub-centers are still recruiting personnel.
The initial drug review center will guide them to strengthen communication with local R&D companies, and increase business functions after they have the review capabilities
.
The audit center merged together to do it
.
At present, the two sub-centers are still recruiting personnel.
The initial drug review center will guide them to strengthen communication with local R&D companies, and increase business functions after they have the review capabilities
.
In recent years, under the support of national policies and laws and regulations , China has built a relatively complete pharmaceutical innovation ecosystem.
Some local companies have increased their R&D investment from 10% to 20%.
China's innovation contribution to the world The rate is also increasing
.
Under the mutual support and promotion of high-level drug review institutions and high-quality medical innovation, Kong Fanpu said that there will be more innovative and good drugs to serve the public in the future, and many clinical treatment problems will gradually be solved
.
Some local companies have increased their R&D investment from 10% to 20%.
China's innovation contribution to the world The rate is also increasing
.
Under the mutual support and promotion of high-level drug review institutions and high-quality medical innovation, Kong Fanpu said that there will be more innovative and good drugs to serve the public in the future, and many clinical treatment problems will gradually be solved
.
Medical Network News, August 25.
In recent years, the national policy to encourage drug innovation has continued to increase, and batches of clinically urgently needed drugs have been approved to enter the market
.
According to data obtained by a reporter from the National Food and Drug Administration of the "Pharmaceutical Economic News", 21 Class 1 innovative drugs have been approved for marketing in the first half of 2021.
This number has exceeded the number of 20 innovative drugs approved for the whole year of 2020.
This also means that China has set a new record in the review of innovative drugs
.
In recent years, the national policy to encourage drug innovation has continued to increase, and batches of clinically urgently needed drugs have been approved to enter the market
.
According to data obtained by a reporter from the National Food and Drug Administration of the "Pharmaceutical Economic News", 21 Class 1 innovative drugs have been approved for marketing in the first half of 2021.
This number has exceeded the number of 20 innovative drugs approved for the whole year of 2020.
This also means that China has set a new record in the review of innovative drugs
.
From the perspective of the treatment field, these products mainly involve the prevention and treatment drugs needed for emergency public health emergencies, and urgently needed clinical drugs such as tumors, rare diseases and immune system diseases, many of which are independently developed by China and have independent intellectual property rights
.
.
As we all know, after the outbreak of the new crown pneumonia, the task of special approval for the prevention and treatment of new crown pneumonia is very heavy
.
As of June 30, 4 new crown vaccines have been conditionally approved for marketing, 22 vaccines and 19 therapeutic biological products (including 12 neutralizing antibodies) have been approved for clinical trials through special approval procedures; "Tripartite" related Chinese medicine varieties (Qingfei Paidu Granules, Huashi Baidu Granules, Xuanfei Baidu Granules) were approved for marketing
.
.
As of June 30, 4 new crown vaccines have been conditionally approved for marketing, 22 vaccines and 19 therapeutic biological products (including 12 neutralizing antibodies) have been approved for clinical trials through special approval procedures; "Tripartite" related Chinese medicine varieties (Qingfei Paidu Granules, Huashi Baidu Granules, Xuanfei Baidu Granules) were approved for marketing
.
Under the tremendous pressure of emergency review of products for the prevention and treatment of new coronary pneumonia, how has the number of innovative drugs approved to break the record? Kong Fanpu, director of the Center for Drug Evaluation of the State Drug Administration, informed that this is inseparable from a series of "combined punches" in the reform of the drug review and approval system in recent years
.
.
He pointed out that in order to meet the innovation needs of the pharmaceutical industry, in July 2020, the Center for Drug Evaluation has opened a number of channels to speed up the listing and registration of drugs
.
This series of approaches is to use limited review resources on innovative drugs and urgently needed drugs with obvious clinical value
.
After recent years of practice and optimization, these reform measures have begun to gradually take effect
.
.
This series of approaches is to use limited review resources on innovative drugs and urgently needed drugs with obvious clinical value
.
After recent years of practice and optimization, these reform measures have begun to gradually take effect
.
Over 90% completed within the time limit
When it comes to the review and approval of Chinese drugs, we have never forgotten the peak time when the backlog reached 22,000
.
Kong Fanpu recalled that when he took up his post at the Drug Evaluation Center at the end of 2018, the relevant policies for the reform of the drug review and approval system had not yet been fully implemented, and the "Drug Registration Management Measures" had not yet adapted to the requirements of the reform of the drug review and approval system.
The bureau leaders also instructed the need to quickly solve the difficult problems in the reform
.
.
Kong Fanpu recalled that when he took up his post at the Drug Evaluation Center at the end of 2018, the relevant policies for the reform of the drug review and approval system had not yet been fully implemented, and the "Drug Registration Management Measures" had not yet adapted to the requirements of the reform of the drug review and approval system.
The bureau leaders also instructed the need to quickly solve the difficult problems in the reform
.
In order to promote the modernization of the drug review system and review capabilities, the Center for Drug Review began to build a drug review process-oriented scientific management system, and divided the entire review work into 8 links according to the process, including task acceptance, task allocation, and professional review , Comprehensive review, communication, expert consultation, written supplement, verification and inspection
.
Each link has set up a research team, and based on the research problems, proposed improvement measures, and gradually applied to the revision of the supporting documents of the "Administrative Measures for Drug Registration"
.
.
Each link has set up a research team, and based on the research problems, proposed improvement measures, and gradually applied to the revision of the supporting documents of the "Administrative Measures for Drug Registration"
.
Incomplete statistics show that in the revision of the supporting documents of the "Administrative Measures for Drug Registration," 30 were completed by the Center for Drug Evaluation
.
.
"Since then, we have improved the review quality and review efficiency by revising supporting documents and drafting guidelines
.
" Kong Fanpu said that the most impressive thing is the opening and optimization of four drug registration procedures: breakthrough treatment, conditional approval, priority review and approval, and special approval
.
In order to use the limited review resources on innovative drugs and urgently needed drugs with obvious clinical value, priority reviews have been reduced from the original 18 items to 5 in accordance with clinical urgent needs
.
The special approval has made a breakthrough in the new crown epidemic last year.
Early intervention, continuous tracking, rolling submission, and joint research and review have ensured the rapid development and marketing of new crown vaccines and new crown drugs
.
.
" Kong Fanpu said that the most impressive thing is the opening and optimization of four drug registration procedures: breakthrough treatment, conditional approval, priority review and approval, and special approval
.
In order to use the limited review resources on innovative drugs and urgently needed drugs with obvious clinical value, priority reviews have been reduced from the original 18 items to 5 in accordance with clinical urgent needs
.
The special approval has made a breakthrough in the new crown epidemic last year.
Early intervention, continuous tracking, rolling submission, and joint research and review have ensured the rapid development and marketing of new crown vaccines and new crown drugs
.
Kong Fanpu said that on the basis of summing up the experience of special approval of anti-epidemic products, these methods will be gradually applied to the review of innovative drugs in the future
.
.
According to the data, in the first half of 2021, 5802 registration application tasks were accepted (calculated by acceptance number), a year-on-year increase of 15.
14%; 4,819 cases were closed, a year-on-year increase of 19.
55 percent, and the overall completion rate of completed tasks within the time limit was 98.
22%
.
With the year-on-year increase in the number of drug registration application tasks and the high technical content of the declared varieties, the overall completion rate of the innovative drug-related tasks of the Center for Drug Evaluation exceeded 90% within the time limit
.
14%; 4,819 cases were closed, a year-on-year increase of 19.
55 percent, and the overall completion rate of completed tasks within the time limit was 98.
22%
.
With the year-on-year increase in the number of drug registration application tasks and the high technical content of the declared varieties, the overall completion rate of the innovative drug-related tasks of the Center for Drug Evaluation exceeded 90% within the time limit
.
In recent years, the Center for Drug Evaluation has not forgotten to benchmark against the latest international practices
.
The US FDA’s Prescription Drug Payment Act (PDUFA) allows pharmaceutical companies to pay application fees to help review agencies increase manpower and material resources, but the completion rate of review tasks within the time limit must reach 90%
.
Kong Fanpu said frankly, "We could not achieve this completion rate last year, but in the first half of this year, whether it is innovative drugs or generic drugs, the overall review completion rate has exceeded this level
.
"
.
The US FDA’s Prescription Drug Payment Act (PDUFA) allows pharmaceutical companies to pay application fees to help review agencies increase manpower and material resources, but the completion rate of review tasks within the time limit must reach 90%
.
Kong Fanpu said frankly, "We could not achieve this completion rate last year, but in the first half of this year, whether it is innovative drugs or generic drugs, the overall review completion rate has exceeded this level
.
"
Accelerate the construction of standards
In order to guide enterprises to avoid detours in R&D and effectively shorten the process of new drug R&D, the Center for Drug Evaluation has also made bold attempts in recent years
.
.
In 2020, the Center for Drug Evaluation has drafted 119 technical guidelines and officially issued 71.
On this basis, another 37 will be issued in the first half of 2021
.
There are 102 plans to be formulated for the whole year of 2021, covering multiple fields such as new coronary pneumonia prevention and treatment drugs, traditional Chinese medicines, chemical drugs, biological products, children's medicines, and individual medicines.
All of them have been launched, and 12 of them are being solicited for comments, and public comments have been completed.
Of the 24, 12 have been submitted to the National Bureau for review, and 2 will be released soon after review and approval by the National Bureau
.
On this basis, another 37 will be issued in the first half of 2021
.
There are 102 plans to be formulated for the whole year of 2021, covering multiple fields such as new coronary pneumonia prevention and treatment drugs, traditional Chinese medicines, chemical drugs, biological products, children's medicines, and individual medicines.
All of them have been launched, and 12 of them are being solicited for comments, and public comments have been completed.
Of the 24, 12 have been submitted to the National Bureau for review, and 2 will be released soon after review and approval by the National Bureau
.
Kong Fanpu explained, “Before 2020, we have only 204 drug development technology guidelines.
In the past two years, we have added more than 100, and the total number has exceeded 300.
Next year, this number will increase significantly
.
At present, judging from the number of issued guidelines, the EU has more than 400, and the United States has more than the EU
.
" This also shows that China's drug review system is accelerating on the international track
.
In the past two years, we have added more than 100, and the total number has exceeded 300.
Next year, this number will increase significantly
.
At present, judging from the number of issued guidelines, the EU has more than 400, and the United States has more than the EU
.
" This also shows that China's drug review system is accelerating on the international track
.
In addition, the Center for Drug Evaluation has also continuously explored and issued the "Guiding Principles for Real-World Data for Generating Real-World Evidence (Trial)" to promote the establishment of a real-world research-related guiding principle system that can effectively guide practice
.
.
During the interview, the reporter learned that real-world research plays a key role in supplementing children's medication information
.
Due to the difficulty in implementing children's clinical research, how to use existing research data to support children's drug research and development and clinical rational use is a common problem faced by global regulatory agencies
.
.
Due to the difficulty in implementing children's clinical research, how to use existing research data to support children's drug research and development and clinical rational use is a common problem faced by global regulatory agencies
.
Kong Fanpu said that in the next step, the drug review center will conduct retrospective studies or explore real-world data to support the development of children’s drugs for drugs that have not yet been approved for use in children around the world, but domestic and foreign guidelines have clearly recommended drugs for use in children.
Provide evidence for children's use, support the expansion of indications in the instructions, solve the problem of clinical empirical drug delivery, and eliminate the hidden dangers of children's drug use in the majority of families
.
Provide evidence for children's use, support the expansion of indications in the instructions, solve the problem of clinical empirical drug delivery, and eliminate the hidden dangers of children's drug use in the majority of families
.
In addition, in encouraging innovation in traditional Chinese medicine
.
Kong Fanpu said that the evaluation of traditional Chinese medicine should not only adhere to modern evaluation methods, but also pay attention to the importance of traditional Chinese medicine inheritance
.
Combining the clinical practice of the "three prescriptions" of traditional Chinese medicine in the anti-epidemic, the Center for Drug Evaluation has accelerated the completion of the transformation of anti-epidemic results in accordance with category 3.
2 "other traditional Chinese medicine compound preparations derived from ancient classic prescriptions" for the first time
.
In the next step, the Center for Drug Evaluation will refer to the review experience of the "three prescriptions" related varieties, implement the work requirements for the establishment of an expert review committee for ancient classic Chinese medicine compound preparations, and gradually explore the review work procedures and technical requirements that meet the characteristics of traditional Chinese medicine
.
.
Kong Fanpu said that the evaluation of traditional Chinese medicine should not only adhere to modern evaluation methods, but also pay attention to the importance of traditional Chinese medicine inheritance
.
Combining the clinical practice of the "three prescriptions" of traditional Chinese medicine in the anti-epidemic, the Center for Drug Evaluation has accelerated the completion of the transformation of anti-epidemic results in accordance with category 3.
2 "other traditional Chinese medicine compound preparations derived from ancient classic prescriptions" for the first time
.
In the next step, the Center for Drug Evaluation will refer to the review experience of the "three prescriptions" related varieties, implement the work requirements for the establishment of an expert review committee for ancient classic Chinese medicine compound preparations, and gradually explore the review work procedures and technical requirements that meet the characteristics of traditional Chinese medicine
.
The number of acceptances has risen sharply
It is not difficult to see from the annual review report issued by the Center for Drug Evaluation in recent years that the number of drug acceptances has shown a "straight line" increase: 3779 in 2016, 4837 in 2017, 7336 in 2018, 8082 in 2019, 2020 There are more than 10,000 pieces in the year
.
Incomplete statistics show that during the epidemic, the acceptance volume of the Center for Drug Evaluation increased by 26%
.
.
Incomplete statistics show that during the epidemic, the acceptance volume of the Center for Drug Evaluation increased by 26%
.
"If we continue to do this for a long time, manpower will not be possible
.
" Kong Fanpu said frankly, "From the perspective of the number of acceptances in recent years, we have more supplementary applications than the US FDA.
The FDA's CDER and CBER now have more than 7,000 people.
There are only more than 700 people in the audit center, and there is a serious shortage of manpower
.
The methods and methods we summarized in the reform implementation are difficult to implement due to insufficient manpower
.
For example, we intervened in advance.
In 2016, we only had more than 300 communication applications.
Last year we communicated and communicated.
The number of applications has reached more than 3,000.
Although it is a 10-fold increase, it still cannot meet the needs of corporate communication
.
"
.
" Kong Fanpu said frankly, "From the perspective of the number of acceptances in recent years, we have more supplementary applications than the US FDA.
The FDA's CDER and CBER now have more than 7,000 people.
There are only more than 700 people in the audit center, and there is a serious shortage of manpower
.
The methods and methods we summarized in the reform implementation are difficult to implement due to insufficient manpower
.
For example, we intervened in advance.
In 2016, we only had more than 300 communication applications.
Last year we communicated and communicated.
The number of applications has reached more than 3,000.
Although it is a 10-fold increase, it still cannot meet the needs of corporate communication
.
"
In recent years, the dividends of innovative drugs have been gradually released, and the number of applications accepted has also risen sharply.
The Center for Drug Evaluation has acted as the “helmsman” leading the industry in research and development
.
How to guide the rational development of enterprises?
The Center for Drug Evaluation has acted as the “helmsman” leading the industry in research and development
.
How to guide the rational development of enterprises?
Kong Fanpu said that it is undeniable that while encouraging enterprise innovation, individual fields have also experienced overheating, which is called "pseudo-innovation" by the R&D community
.
The fundamental purpose of drug marketing is to solve the needs of patients, and drug research and development should focus on patient needs and be oriented by clinical value
.
The Center for Drug Evaluation will also pay attention to the guidance in this regard in the formulation and revision of the guidelines, and use the limited R&D resources and review resources to solve urgent clinical needs
.
.
The fundamental purpose of drug marketing is to solve the needs of patients, and drug research and development should focus on patient needs and be oriented by clinical value
.
The Center for Drug Evaluation will also pay attention to the guidance in this regard in the formulation and revision of the guidelines, and use the limited R&D resources and review resources to solve urgent clinical needs
.
At the same time, with regard to the functions of the Yangtze River Delta Sub-center of the Pharmaceutical Industry and the Pharmaceutical Dawan Sub-center, which are more concerned by the industry , Kong Fanpu responded that these two sub-centers are located in the active area of the medical industry.
The audit center merged together to do it
.
At present, the two sub-centers are still recruiting personnel.
The initial drug review center will guide them to strengthen communication with local R&D companies, and increase business functions after they have the review capabilities
.
The audit center merged together to do it
.
At present, the two sub-centers are still recruiting personnel.
The initial drug review center will guide them to strengthen communication with local R&D companies, and increase business functions after they have the review capabilities
.
In recent years, under the support of national policies and laws and regulations , China has built a relatively complete pharmaceutical innovation ecosystem.
Some local companies have increased their R&D investment from 10% to 20%.
China's innovation contribution to the world The rate is also increasing
.
Under the mutual support and promotion of high-level drug review institutions and high-quality medical innovation, Kong Fanpu said that there will be more innovative and good drugs to serve the public in the future, and many clinical treatment problems will gradually be solved
.
Some local companies have increased their R&D investment from 10% to 20%.
China's innovation contribution to the world The rate is also increasing
.
Under the mutual support and promotion of high-level drug review institutions and high-quality medical innovation, Kong Fanpu said that there will be more innovative and good drugs to serve the public in the future, and many clinical treatment problems will gradually be solved
.
Medical Network News, August 25.
In recent years, the national policy to encourage drug innovation has continued to increase, and batches of clinically urgently needed drugs have been approved to enter the market
.
According to data obtained by a reporter from the National Food and Drug Administration of the "Pharmaceutical Economic News", 21 Class 1 innovative drugs have been approved for marketing in the first half of 2021.
This number has exceeded the number of 20 innovative drugs approved for the whole year of 2020.
This also means that China has set a new record in the review of innovative drugs
.
In recent years, the national policy to encourage drug innovation has continued to increase, and batches of clinically urgently needed drugs have been approved to enter the market
.
According to data obtained by a reporter from the National Food and Drug Administration of the "Pharmaceutical Economic News", 21 Class 1 innovative drugs have been approved for marketing in the first half of 2021.
This number has exceeded the number of 20 innovative drugs approved for the whole year of 2020.
This also means that China has set a new record in the review of innovative drugs
.
From the perspective of the treatment field, these products mainly involve the prevention and treatment drugs needed for emergency public health emergencies, and urgently needed clinical drugs such as tumors, rare diseases and immune system diseases, many of which are independently developed by China and have independent intellectual property rights
.
.
As we all know, after the outbreak of the new crown pneumonia, the task of special approval for the prevention and treatment of new crown pneumonia is very heavy
.
As of June 30, 4 new crown vaccines have been conditionally approved for marketing, 22 vaccines and 19 therapeutic biological products (including 12 neutralizing antibodies) have been approved for clinical trials through special approval procedures; "Tripartite" related Chinese medicine varieties (Qingfei Paidu Granules, Huashi Baidu Granules, Xuanfei Baidu Granules) were approved for marketing
.
.
As of June 30, 4 new crown vaccines have been conditionally approved for marketing, 22 vaccines and 19 therapeutic biological products (including 12 neutralizing antibodies) have been approved for clinical trials through special approval procedures; "Tripartite" related Chinese medicine varieties (Qingfei Paidu Granules, Huashi Baidu Granules, Xuanfei Baidu Granules) were approved for marketing
.
Under the tremendous pressure of emergency review of products for the prevention and treatment of new coronary pneumonia, how has the number of innovative drugs approved to break the record? Kong Fanpu, director of the Center for Drug Evaluation of the State Drug Administration, informed that this is inseparable from a series of "combined punches" in the reform of the drug review and approval system in recent years
.
.
He pointed out that in order to meet the innovation needs of the pharmaceutical industry, in July 2020, the Center for Drug Evaluation has opened a number of channels to speed up the listing and registration of drugs
.
This series of approaches is to use limited review resources on innovative drugs and urgently needed drugs with obvious clinical value
.
After recent years of practice and optimization, these reform measures have begun to gradually take effect
.
.
This series of approaches is to use limited review resources on innovative drugs and urgently needed drugs with obvious clinical value
.
After recent years of practice and optimization, these reform measures have begun to gradually take effect
.
Over 90% completed within the time limit
Over 90% completed within the time limit When it comes to the review and approval of Chinese drugs, we have never forgotten the peak time when the backlog reached 22,000
.
Kong Fanpu recalled that when he took up his post at the Drug Evaluation Center at the end of 2018, the relevant policies for the reform of the drug review and approval system had not yet been fully implemented, and the "Drug Registration Management Measures" had not yet adapted to the requirements of the reform of the drug review and approval system.
The bureau leaders also instructed the need to quickly solve the difficult problems in the reform
.
.
Kong Fanpu recalled that when he took up his post at the Drug Evaluation Center at the end of 2018, the relevant policies for the reform of the drug review and approval system had not yet been fully implemented, and the "Drug Registration Management Measures" had not yet adapted to the requirements of the reform of the drug review and approval system.
The bureau leaders also instructed the need to quickly solve the difficult problems in the reform
.
In order to promote the modernization of the drug review system and review capabilities, the Center for Drug Review began to build a drug review process-oriented scientific management system, and divided the entire review work into 8 links according to the process, including task acceptance, task allocation, and professional review , Comprehensive review, communication, expert consultation, written supplement, verification and inspection
.
Each link has set up a research team, and based on the research problems, proposed improvement measures, and gradually applied to the revision of the supporting documents of the "Administrative Measures for Drug Registration"
.
.
Each link has set up a research team, and based on the research problems, proposed improvement measures, and gradually applied to the revision of the supporting documents of the "Administrative Measures for Drug Registration"
.
Incomplete statistics show that in the revision of the supporting documents of the "Administrative Measures for Drug Registration," 30 were completed by the Center for Drug Evaluation
.
.
"Since then, we have improved the review quality and review efficiency by revising supporting documents and drafting guidelines
.
" Kong Fanpu said that the most impressive thing is the opening and optimization of four drug registration procedures: breakthrough treatment, conditional approval, priority review and approval, and special approval
.
In order to use the limited review resources on innovative drugs and urgently needed drugs with obvious clinical value, priority reviews have been reduced from the original 18 items to 5 in accordance with clinical urgent needs
.
The special approval has made a breakthrough in the new crown epidemic last year.
Early intervention, continuous tracking, rolling submission, and joint research and review have ensured the rapid development and marketing of new crown vaccines and new crown drugs
.
.
" Kong Fanpu said that the most impressive thing is the opening and optimization of four drug registration procedures: breakthrough treatment, conditional approval, priority review and approval, and special approval
.
In order to use the limited review resources on innovative drugs and urgently needed drugs with obvious clinical value, priority reviews have been reduced from the original 18 items to 5 in accordance with clinical urgent needs
.
The special approval has made a breakthrough in the new crown epidemic last year.
Early intervention, continuous tracking, rolling submission, and joint research and review have ensured the rapid development and marketing of new crown vaccines and new crown drugs
.
Kong Fanpu said that on the basis of summing up the experience of special approval of anti-epidemic products, these methods will be gradually applied to the review of innovative drugs in the future
.
.
According to the data, in the first half of 2021, 5802 registration application tasks were accepted (calculated by acceptance number), a year-on-year increase of 15.
14%; 4,819 cases were closed, a year-on-year increase of 19.
55 percent, and the overall completion rate of completed tasks within the time limit was 98.
22%
.
With the year-on-year increase in the number of drug registration application tasks and the high technical content of the declared varieties, the overall completion rate of the innovative drug-related tasks of the Center for Drug Evaluation exceeded 90% within the time limit
.
14%; 4,819 cases were closed, a year-on-year increase of 19.
55 percent, and the overall completion rate of completed tasks within the time limit was 98.
22%
.
With the year-on-year increase in the number of drug registration application tasks and the high technical content of the declared varieties, the overall completion rate of the innovative drug-related tasks of the Center for Drug Evaluation exceeded 90% within the time limit
.
In recent years, the Center for Drug Evaluation has not forgotten to benchmark against the latest international practices
.
The US FDA’s Prescription Drug Payment Act (PDUFA) allows pharmaceutical companies to pay application fees to help review agencies increase manpower and material resources, but the completion rate of review tasks within the time limit must reach 90%
.
Kong Fanpu said frankly, "We could not achieve this completion rate last year, but in the first half of this year, whether it is innovative drugs or generic drugs, the overall review completion rate has exceeded this level
.
"
.
The US FDA’s Prescription Drug Payment Act (PDUFA) allows pharmaceutical companies to pay application fees to help review agencies increase manpower and material resources, but the completion rate of review tasks within the time limit must reach 90%
.
Kong Fanpu said frankly, "We could not achieve this completion rate last year, but in the first half of this year, whether it is innovative drugs or generic drugs, the overall review completion rate has exceeded this level
.
"
Accelerate the construction of standards
Accelerate the construction of standards In order to guide enterprises to avoid detours in R&D and effectively shorten the process of new drug R&D, the Center for Drug Evaluation has also made bold attempts in recent years
.
.
In 2020, the Center for Drug Evaluation has drafted 119 technical guidelines and officially issued 71.
On this basis, another 37 will be issued in the first half of 2021
.
There are 102 plans to be formulated for the whole year of 2021, covering multiple fields such as new coronary pneumonia prevention and treatment drugs, traditional Chinese medicines, chemical drugs, biological products, children's medicines, and individual medicines.
All of them have been launched, and 12 of them are being solicited for comments, and public comments have been completed.
Of the 24, 12 have been submitted to the National Bureau for review, and 2 will be released soon after review and approval by the National Bureau
.
On this basis, another 37 will be issued in the first half of 2021
.
There are 102 plans to be formulated for the whole year of 2021, covering multiple fields such as new coronary pneumonia prevention and treatment drugs, traditional Chinese medicines, chemical drugs, biological products, children's medicines, and individual medicines.
All of them have been launched, and 12 of them are being solicited for comments, and public comments have been completed.
Of the 24, 12 have been submitted to the National Bureau for review, and 2 will be released soon after review and approval by the National Bureau
.
Kong Fanpu explained, “Before 2020, we have only 204 drug development technology guidelines.
In the past two years, we have added more than 100, and the total number has exceeded 300.
Next year, this number will increase significantly
.
At present, judging from the number of issued guidelines, the EU has more than 400, and the United States has more than the EU
.
" This also shows that China's drug review system is accelerating on the international track
.
In the past two years, we have added more than 100, and the total number has exceeded 300.
Next year, this number will increase significantly
.
At present, judging from the number of issued guidelines, the EU has more than 400, and the United States has more than the EU
.
" This also shows that China's drug review system is accelerating on the international track
.
In addition, the Center for Drug Evaluation has also continuously explored and issued the "Guiding Principles for Real-World Data for Generating Real-World Evidence (Trial)" to promote the establishment of a real-world research-related guiding principle system that can effectively guide practice
.
.
During the interview, the reporter learned that real-world research plays a key role in supplementing children's medication information
.
Due to the difficulty in implementing children's clinical research, how to use existing research data to support children's drug research and development and clinical rational use is a common problem faced by global regulatory agencies
.
.
Due to the difficulty in implementing children's clinical research, how to use existing research data to support children's drug research and development and clinical rational use is a common problem faced by global regulatory agencies
.
Kong Fanpu said that in the next step, the drug review center will conduct retrospective studies or explore real-world data to support the development of children’s drugs for drugs that have not yet been approved for use in children around the world, but domestic and foreign guidelines have clearly recommended drugs for use in children.
Provide evidence for children's use, support the expansion of indications in the instructions, solve the problem of clinical empirical drug delivery, and eliminate the hidden dangers of children's drug use in the majority of families
.
Provide evidence for children's use, support the expansion of indications in the instructions, solve the problem of clinical empirical drug delivery, and eliminate the hidden dangers of children's drug use in the majority of families
.
In addition, in encouraging innovation in traditional Chinese medicine
.
Kong Fanpu said that the evaluation of traditional Chinese medicine should not only adhere to modern evaluation methods, but also pay attention to the importance of traditional Chinese medicine inheritance
.
Combining the clinical practice of the "three prescriptions" of traditional Chinese medicine in the anti-epidemic, the Center for Drug Evaluation has accelerated the completion of the transformation of anti-epidemic results in accordance with category 3.
2 "other traditional Chinese medicine compound preparations derived from ancient classic prescriptions" for the first time
.
In the next step, the Center for Drug Evaluation will refer to the review experience of the "three prescriptions" related varieties, implement the work requirements for the establishment of an expert review committee for ancient classic Chinese medicine compound preparations, and gradually explore the review work procedures and technical requirements that meet the characteristics of traditional Chinese medicine
.
Chinese Medicine Chinese Medicine Chinese Medicine.
Kong Fanpu said that the evaluation of traditional Chinese medicine should not only adhere to modern evaluation methods, but also pay attention to the importance of traditional Chinese medicine inheritance
.
Combining the clinical practice of the "three prescriptions" of traditional Chinese medicine in the anti-epidemic, the Center for Drug Evaluation has accelerated the completion of the transformation of anti-epidemic results in accordance with category 3.
2 "other traditional Chinese medicine compound preparations derived from ancient classic prescriptions" for the first time
.
In the next step, the Center for Drug Evaluation will refer to the review experience of the "three prescriptions" related varieties, implement the work requirements for the establishment of an expert review committee for ancient classic Chinese medicine compound preparations, and gradually explore the review work procedures and technical requirements that meet the characteristics of traditional Chinese medicine
.
The number of acceptances has risen sharply
The number of acceptances has risen sharply It is not difficult to see from the annual review report issued by the Center for Drug Evaluation in recent years that the number of drug acceptances has shown a "straight line" increase: 3779 in 2016, 4837 in 2017, 7336 in 2018, 8082 in 2019, 2020 There are more than 10,000 pieces in the year
.
Incomplete statistics show that during the epidemic, the acceptance volume of the Center for Drug Evaluation increased by 26%
.
.
Incomplete statistics show that during the epidemic, the acceptance volume of the Center for Drug Evaluation increased by 26%
.
"If we continue to do this for a long time, manpower will not be possible
.
" Kong Fanpu said frankly, "From the perspective of the number of acceptances in recent years, we have more supplementary applications than the US FDA.
The FDA's CDER and CBER now have more than 7,000 people.
There are only more than 700 people in the audit center, and there is a serious shortage of manpower
.
The methods and methods we summarized in the reform implementation are difficult to implement due to insufficient manpower
.
For example, we intervened in advance.
In 2016, we only had more than 300 communication applications.
Last year we communicated and communicated.
The number of applications has reached more than 3,000.
Although it is a 10-fold increase, it still cannot meet the needs of corporate communication
.
"
.
" Kong Fanpu said frankly, "From the perspective of the number of acceptances in recent years, we have more supplementary applications than the US FDA.
The FDA's CDER and CBER now have more than 7,000 people.
There are only more than 700 people in the audit center, and there is a serious shortage of manpower
.
The methods and methods we summarized in the reform implementation are difficult to implement due to insufficient manpower
.
For example, we intervened in advance.
In 2016, we only had more than 300 communication applications.
Last year we communicated and communicated.
The number of applications has reached more than 3,000.
Although it is a 10-fold increase, it still cannot meet the needs of corporate communication
.
"
In recent years, the dividends of innovative drugs have been gradually released, and the number of applications accepted has also risen sharply.
The Center for Drug Evaluation has acted as the “helmsman” leading the industry in research and development
.
How to guide the rational development of enterprises?
The Center for Drug Evaluation has acted as the “helmsman” leading the industry in research and development
.
How to guide the rational development of enterprises?
Kong Fanpu said that it is undeniable that while encouraging enterprise innovation, individual fields have also experienced overheating, which is called "pseudo-innovation" by the R&D community
.
The fundamental purpose of drug marketing is to solve the needs of patients, and drug research and development should focus on patient needs and be oriented by clinical value
.
The Center for Drug Evaluation will also pay attention to the guidance in this regard in the formulation and revision of the guidelines, and use the limited R&D resources and review resources to solve urgent clinical needs
.
.
The fundamental purpose of drug marketing is to solve the needs of patients, and drug research and development should focus on patient needs and be oriented by clinical value
.
The Center for Drug Evaluation will also pay attention to the guidance in this regard in the formulation and revision of the guidelines, and use the limited R&D resources and review resources to solve urgent clinical needs
.
At the same time, with regard to the functions of the Yangtze River Delta Sub-center of the Pharmaceutical Industry and the Pharmaceutical Dawan Sub-center, which are more concerned by the industry , Kong Fanpu responded that these two sub-centers are located in the active area of the medical industry.
The audit center merged together to do it
.
At present, the two sub-centers are still recruiting personnel.
The initial drug review center will guide them to strengthen communication with local R&D companies, and increase business functions after they have the review capabilities
.
Medicine, medicine, medicineThe audit center merged together to do it
.
At present, the two sub-centers are still recruiting personnel.
The initial drug review center will guide them to strengthen communication with local R&D companies, and increase business functions after they have the review capabilities
.
In recent years, under the support of national policies and laws and regulations , China has built a relatively complete pharmaceutical innovation ecosystem.
Some local companies have increased their R&D investment from 10% to 20%.
China's innovation contribution to the world The rate is also increasing
.
Under the mutual support and promotion of high-level drug review institutions and high-quality medical innovation, Kong Fanpu said that there will be more innovative and good drugs to serve the public in the future, and many clinical treatment problems will gradually be solved
.
Laws and regulations and regulations pharmaceutical medicine pharmaceutical companies business enterprises Some local companies have increased their R&D investment from 10% to 20%.
China's innovation contribution to the world The rate is also increasing
.
Under the mutual support and promotion of high-level drug review institutions and high-quality medical innovation, Kong Fanpu said that there will be more innovative and good drugs to serve the public in the future, and many clinical treatment problems will gradually be solved
.
