Exclusive interview with CDE director Kong Fanpu: Innovative drug review set a new record, and the international drug review track accelerated

In recent years, the country’s policy dividend for encouraging drug innovation has continued to increase, and batches of clinically urgently needed drugs have been approved to enter the market

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

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

Over 90% completed within the time limit

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 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.

  In recent years, the Center for Drug Evaluation has not forgotten to benchmark against the latest international practices

Accelerate the construction of standards

  Kong Fanpu explained, “Before 2020, we have only 204 drug development technology guidelines.

  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

  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.

  In addition, in encouraging innovation in traditional Chinese medicine
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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
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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
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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
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The number of acceptances has risen sharply

  "If we continue to do this for a long time, manpower will not be possible
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" 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
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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
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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
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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
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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
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  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
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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
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  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
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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
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