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In order to encourage the declaration of research and development of radioactive drugs, the State Drug Administration has organized and drafted the Opinions on Reforming and Improving the Administration of Review and Approval of Radioactive Drugs (Draft for Solicitation of Comments), which is now open to the public for comments
.
.
Before October 31, 2022, please feedback the relevant opinions to the hxypc@nmpa.
gov.
cn of the email address in accordance with the format requirements of the "Feedback Form", please indicate "Reform and improve the review and approval management of radioactive drugs"
.
gov.
cn of the email address in accordance with the format requirements of the "Feedback Form", please indicate "Reform and improve the review and approval management of radioactive drugs"
.
Annex: 1.
Opinions of the State Food and Drug Administration on Reforming and Improving the Administration of Review and Approval of Radioactive Drugs (Draft for Solicitation of Comments)
Opinions of the State Food and Drug Administration on Reforming and Improving the Administration of Review and Approval of Radioactive Drugs (Draft for Solicitation of Comments)
2.
Feedback form of the Opinions of the State Food and Drug Administration on Reforming and Improving the Administration of Review and Approval of Radioactive Drugs (Draft for Solicitation of Comments).
Feedback form of the Opinions of the State Food and Drug Administration on Reforming and Improving the Administration of Review and Approval of Radioactive Drugs (Draft for Solicitation of Comments).
Appendix 1 Opinions of the State Food and Drug Administration on Reforming and Improving the Administration of Review and Approval of Radioactive Drugs (Draft for Solicitation of Comments) .
doc
doc
Appendix 2 Feedback Form for the Opinions of the State Food and Drug Administration on Reforming and Improving the Administration of Review and Approval of Radioactive Drugs (Draft for Solicitation of Comments) .
doc
doc
Comprehensive Department of the State Food and Drug Administration
September 30, 2022
Annex 1
The State Food and Drug Administration on the reform and improvement of radiopharmaceuticals
Review the opinions of the approval management
(Draft for Solicitation of Comments)
All provinces, autonomous regions, municipalities directly under the Central Government, and the Drug Supervision and Administration Bureau of the Xinjiang Production and Construction Corps, and the State Food and Drug Administration:
Radiopharmaceuticals play a special role
in the diagnosis and treatment of malignant tumors and cardiovascular and cerebrovascular diseases.
In recent years, under the great attention of the Party Central Committee and the State Council, through deepening the reform of the drug review and approval system, important progress has been made in the research and development and application of radioactive drugs, but there is still a certain gap with
the international advanced level.
In order to meet clinical needs, encourage the research and development of radioactive drugs, combined with the actual situation of drug supervision, the following reform opinions are proposed:
in the diagnosis and treatment of malignant tumors and cardiovascular and cerebrovascular diseases.
In recent years, under the great attention of the Party Central Committee and the State Council, through deepening the reform of the drug review and approval system, important progress has been made in the research and development and application of radioactive drugs, but there is still a certain gap with
the international advanced level.
In order to meet clinical needs, encourage the research and development of radioactive drugs, combined with the actual situation of drug supervision, the following reform opinions are proposed:
First, the work objectives
Adhere to the people-centered development thinking, take clinical value as the guide, and encourage the declaration
of radioactive drug research and development.
Adhere to the "four strictest" requirements to ensure that radiopharmaceuticals are safe, effective and quality controllable
.
Adhere to the problem-oriented, combined with the characteristics of radiopharmaceuticals, take into account flexibility on a scientific basis, and reform and improve the review and approval work
.
of radioactive drug research and development.
Adhere to the "four strictest" requirements to ensure that radiopharmaceuticals are safe, effective and quality controllable
.
Adhere to the problem-oriented, combined with the characteristics of radiopharmaceuticals, take into account flexibility on a scientific basis, and reform and improve the review and approval work
.
Second, key tasks
(1) Expand the team of experts and give full play to the role of
experts.
In the major decisions of radiopharmaceutical supervision, the opinions
of academicians of the Chinese Academy of Sciences and the Chinese Academy of Sciences, senior experts and experts with high industry recognition are fully heard.
Expand the team of experts in the review of radiopharmaceuticals, select and absorb multidisciplinary experts who are proficient in radiopharmaceuticals, and give full play to the role
of experts in policy formulation, the formulation and revision of guiding principles, and the review of drug technology.
experts.
In the major decisions of radiopharmaceutical supervision, the opinions
of academicians of the Chinese Academy of Sciences and the Chinese Academy of Sciences, senior experts and experts with high industry recognition are fully heard.
Expand the team of experts in the review of radiopharmaceuticals, select and absorb multidisciplinary experts who are proficient in radiopharmaceuticals, and give full play to the role
of experts in policy formulation, the formulation and revision of guiding principles, and the review of drug technology.
(2) Encourage drug research and development to meet the urgent clinical needs
.
Encourage innovations in radiopharmaceuticals oriented to clinical value, and give priority to the review and approval
of radiopharmaceutical registration applications.
For the review of radiopharmaceuticals, establish a long-term mechanism of early intervention, continuous tracking, active service, and research and review linkage, and strengthen the communication and guidance
of the whole process of research and development declaration.
Strengthen communication and coordination with health authorities, include overseas listed and domestic unlisted radiopharmaceuticals that are urgently needed in clinical practice, into the list of encouraged generic drugs, and guide enterprises in research and development
.
.
Encourage innovations in radiopharmaceuticals oriented to clinical value, and give priority to the review and approval
of radiopharmaceutical registration applications.
For the review of radiopharmaceuticals, establish a long-term mechanism of early intervention, continuous tracking, active service, and research and review linkage, and strengthen the communication and guidance
of the whole process of research and development declaration.
Strengthen communication and coordination with health authorities, include overseas listed and domestic unlisted radiopharmaceuticals that are urgently needed in clinical practice, into the list of encouraged generic drugs, and guide enterprises in research and development
.
(3) Optimize the review mechanism to reflect the particularity of
radioactive drugs.
Improve the technical review system for radiopharmaceuticals, and reflect the characteristics
of radiopharmaceuticals in acceptance, technical review, verification, inspection and other links.
Drawing on international experience, combined with the actual supervision of China, study the management and classification of radioactive particles, microspheres and radioimmunoassay test kits, and study and improve the declaration path and declaration data requirements
of nuclides, generators, cold medicine boxes, etc.
In the acceptance process, formulate and improve the relevant requirements for the acceptance and review of radioactive drugs, and strengthen the guidance for
declaration.
A special channel for radiopharmaceuticals is set up during the review process, and a separate review sequence is
given.
Clarify the release requirements and review technical requirements for generic reference preparations that meet the characteristics of drug dispensing
.
Priority will be given to applications for communication and exchange of radiopharmaceuticals
.
Optimize the working mechanism for registration inspection and registration verification of radiopharmaceuticals, formulate clear batches and inspection volume requirements for radiopharmaceuticals, reduce the burden on enterprises, and improve work efficiency
.
radioactive drugs.
Improve the technical review system for radiopharmaceuticals, and reflect the characteristics
of radiopharmaceuticals in acceptance, technical review, verification, inspection and other links.
Drawing on international experience, combined with the actual supervision of China, study the management and classification of radioactive particles, microspheres and radioimmunoassay test kits, and study and improve the declaration path and declaration data requirements
of nuclides, generators, cold medicine boxes, etc.
In the acceptance process, formulate and improve the relevant requirements for the acceptance and review of radioactive drugs, and strengthen the guidance for
declaration.
A special channel for radiopharmaceuticals is set up during the review process, and a separate review sequence is
given.
Clarify the release requirements and review technical requirements for generic reference preparations that meet the characteristics of drug dispensing
.
Priority will be given to applications for communication and exchange of radiopharmaceuticals
.
Optimize the working mechanism for registration inspection and registration verification of radiopharmaceuticals, formulate clear batches and inspection volume requirements for radiopharmaceuticals, reduce the burden on enterprises, and improve work efficiency
.
(4) Improve the technical evaluation system
.
Fully learn from international experience and improve the technical guiding principle system
for the research and development of radioactive drugs in China.
Accelerate the formulation and revision of the guidelines for pharmacological, pharmacological toxicology and clinical techniques for radiotherapy, study the particularity of the technical requirements for radiopharmaceuticals compared with ordinary chemical drugs, and carry out the formulation of individual drug guidelines in combination with specific varieties
.
Strengthen international academic exchanges, timely research and grasp the requirements of international evaluation standards, and understand the development trend of
cutting-edge technology.
.
Fully learn from international experience and improve the technical guiding principle system
for the research and development of radioactive drugs in China.
Accelerate the formulation and revision of the guidelines for pharmacological, pharmacological toxicology and clinical techniques for radiotherapy, study the particularity of the technical requirements for radiopharmaceuticals compared with ordinary chemical drugs, and carry out the formulation of individual drug guidelines in combination with specific varieties
.
Strengthen international academic exchanges, timely research and grasp the requirements of international evaluation standards, and understand the development trend of
cutting-edge technology.
(5) Strengthen the capacity building
of inspection and inspection.
Rationally plan the construction layout of national radiopharmaceutical inspection institutions, grant some provinces the inspection qualifications of technetium-labeled drugs and positic electron radiopharmaceuticals and the inspection qualifications of some therapeutic radiopharmaceuticals according to the area, and carry out production licenses and medical institutions for filing inspections
nearby.
Combined with the construction of scientific laboratories for the supervision of radiopharmaceuticals, the number of qualified inspection institutions
will be added.
Upgrade the radiation license level of the radiopharmaceutical testing department undertaken by the Central Inspection Institute, and obtain the radiation safety license for
radiopharmaceutical animal laboratories.
Strengthen the construction of radiopharmaceutical inspection and inspection teams, introduce shortage of professional talents, train and assess the backbone of provincial inspection and inspection, and strengthen personnel training
.
Strengthen the equipment for the inspection and testing of radiopharmaceuticals, carry out research on the inspection and testing methods of radioactive innovative drugs and the evaluation methods of radiocopied drugs, and improve the testing capacity and level
of radiopharmaceuticals.
of inspection and inspection.
Rationally plan the construction layout of national radiopharmaceutical inspection institutions, grant some provinces the inspection qualifications of technetium-labeled drugs and positic electron radiopharmaceuticals and the inspection qualifications of some therapeutic radiopharmaceuticals according to the area, and carry out production licenses and medical institutions for filing inspections
nearby.
Combined with the construction of scientific laboratories for the supervision of radiopharmaceuticals, the number of qualified inspection institutions
will be added.
Upgrade the radiation license level of the radiopharmaceutical testing department undertaken by the Central Inspection Institute, and obtain the radiation safety license for
radiopharmaceutical animal laboratories.
Strengthen the construction of radiopharmaceutical inspection and inspection teams, introduce shortage of professional talents, train and assess the backbone of provincial inspection and inspection, and strengthen personnel training
.
Strengthen the equipment for the inspection and testing of radiopharmaceuticals, carry out research on the inspection and testing methods of radioactive innovative drugs and the evaluation methods of radiocopied drugs, and improve the testing capacity and level
of radiopharmaceuticals.
(6) Strengthen the supervision of production and
circulation links.
Strictly examine and approve radioactive drug production and operation enterprises, implement territorial supervision responsibilities and the main responsibilities of marketing authorization holders, require holders to have an appropriate quality management system, and ensure that the drug production process continues to comply with drug production quality management practices and drug registration management requirements, and ensure the quality and safety
of radiopharmaceuticals.
In accordance with the Drug Administration Law, the Measures for the Administration of Changes after the Listing of Drugs (for Trial Implementation) and other laws and regulations, further optimize the approval process, and do a good job in the approval of
changes in the production site of radiopharmaceuticals.
circulation links.
Strictly examine and approve radioactive drug production and operation enterprises, implement territorial supervision responsibilities and the main responsibilities of marketing authorization holders, require holders to have an appropriate quality management system, and ensure that the drug production process continues to comply with drug production quality management practices and drug registration management requirements, and ensure the quality and safety
of radiopharmaceuticals.
In accordance with the Drug Administration Law, the Measures for the Administration of Changes after the Listing of Drugs (for Trial Implementation) and other laws and regulations, further optimize the approval process, and do a good job in the approval of
changes in the production site of radiopharmaceuticals.
(7) Promote the revision
of relevant laws and regulations.
Revise and improve relevant system documents, further standardize and promote the preparation and use
of positron radiopharmaceuticals in medical institutions.
For those who do not meet the requirements of the research and development declaration of radioactive drugs and the development of production supervision, formulate a revision plan for relevant documents, strengthen research, widely listen to the opinions of the industry, and accelerate the introduction
of the revision.
of relevant laws and regulations.
Revise and improve relevant system documents, further standardize and promote the preparation and use
of positron radiopharmaceuticals in medical institutions.
For those who do not meet the requirements of the research and development declaration of radioactive drugs and the development of production supervision, formulate a revision plan for relevant documents, strengthen research, widely listen to the opinions of the industry, and accelerate the introduction
of the revision.
Third, the work requirements
(1) Unify ideological understanding and strengthen organizational leadership
.
Each should improve its political position, adhere to the people-centered, adhere to the clinical needs as the guide, strengthen overall coordination, clarify the division of responsibilities, formulate implementation plans, and pay close attention to the implementation of
the work.
In case of major problems, promptly request a report
in accordance with procedures.
.
Each should improve its political position, adhere to the people-centered, adhere to the clinical needs as the guide, strengthen overall coordination, clarify the division of responsibilities, formulate implementation plans, and pay close attention to the implementation of
the work.
In case of major problems, promptly request a report
in accordance with procedures.
(2) In-depth investigation and research, and improvement of working mechanisms
.
Benchmark the regulatory and technical requirements of international mainstream regulatory agencies, thoroughly study and solve the contradictions and problems encountered in the research and development declaration and production supervision of radioactive drugs in China, rationalize the requirements for the management of radioactive drugs, and promote the smooth development
of related work.
Combined with the formulation and revision and release of the guiding principles, organize and hold academic circles and enterprise symposia to widely listen to opinions and suggestions
.
After the issuance of the guiding principles, timely training will be carried out for radiopharmaceutical research and development institutions and enterprises, and relevant technical requirements and policies
to encourage innovation will be publicized.
.
Benchmark the regulatory and technical requirements of international mainstream regulatory agencies, thoroughly study and solve the contradictions and problems encountered in the research and development declaration and production supervision of radioactive drugs in China, rationalize the requirements for the management of radioactive drugs, and promote the smooth development
of related work.
Combined with the formulation and revision and release of the guiding principles, organize and hold academic circles and enterprise symposia to widely listen to opinions and suggestions
.
After the issuance of the guiding principles, timely training will be carried out for radiopharmaceutical research and development institutions and enterprises, and relevant technical requirements and policies
to encourage innovation will be publicized.
(3) Clarify the division of responsibilities and strengthen supervision and implementation
.
In accordance with the division of work tasks, each formulates a work plan, clarifies the timetable and task map, supervises the implementation of the division of tasks, and ensures the smooth progress of
the reform task.
.
In accordance with the division of work tasks, each formulates a work plan, clarifies the timetable and task map, supervises the implementation of the division of tasks, and ensures the smooth progress of
the reform task.
