Several Opinions of the General Office of the State Council on Further Reform and Improvement of Drug Production, Circulation and Use Policies
Several Opinions of the General Office of the State Council on Further Reform and Improvement of Drug Production, Circulation and Use Policies
Several Opinions of the General Office of the State Council on Further Reform and Improvement of Drug Production, Circulation and Use Policies
Guo Ban Fa [2017] No.13
January 24, 2017
People's governments of all provinces, autonomous regions and municipalities directly under the Central Government, as well as all ministries and commissions of and all institutions directly under the State Council,
In order to deepen the medical and health system reform, improve the quality and efficacy of drugs, regulate the activities of drug circulation and use, better meet the people's requirements for medical advice and treatment, and promote the building of a healthy China, upon approval of the State Council, the following opinions are hereby set out with respect to the further reform and improvement of the policies on drug production, circulation and use:
I. Improving the Quality and Efficacy of Drugs and Promoting the Restructuring of the Pharmaceutical Industry
1. Tightening the evaluation and approval of drug marketing. New drug review shall focus on the clinical value, and generic drug review shall be conducted in the principle that the generic drug in question has the quality and efficacy consistent with that of the brand-name drug. Efforts shall be made to enrich the resources for evaluation, strengthen the guidance for enterprises' research and development, and establish an effective mechanism for ex-ante communication with the applicants, so as to accelerate the settlement of backlog in respect of drug registration applications; optimize the drug evaluation and approval process, and speed up the evaluation and approval of new drugs and medicines in shortage for urgent clinical needs; learn from the advanced international experience, explore the conduct of evaluation and approval by classes including drugs for rare diseases, pediatrics, the elderly and emergency rescue (treatment), as well as traditional Chinese medicines (classical prescriptions), and guarantee the satisfaction of the demands for medicines for the children, the elderly and other populations as well as for prevention and treatment of serious diseases. In respect of any patented drug required for the prevention and treatment of a serious disease, compulsory licensing may be enforced according to the law where necessary. It is imperative to strengthen the verification of clinical trial data and severely punish any data fraud; and fully disclose the information on drug evaluation and approval, and strengthen social supervision.
2. Accelerating the progress in the consistency evaluation for quality and efficacy of generic drugs already available on the market. Drug manufacturers are encouraged to voluntarily purchase reference preparations in accordance with relevant guidelines and reasonably select evaluation methods to carry out research and evaluation. With respect to any reference preparation to be imported, the relevant authorities shall accelerate the approval of import to improve the efficiency of customs clearance. Bioequivalence tests shall be subject to filing management, and qualified medical institutions, universities and colleges, research institutions and other social organizations engaged in testing and inspection are allowed to conduct bioequivalence tests for the consistency evaluation, with the specific implementing measures developed separately. Food and drug regulatory authorities and other departments shall strengthen the guidance on the enterprises to facilitate the completion of the tasks for the consistency evaluation as scheduled. Any drug passing the consistency evaluation will be announced to the public in a timely manner and included in the list of drugs that can be mutually substituted for brand-name drugs. Where there are three or more drug manufacturers for the same drug varieties that have passed the consistency evaluation, the drug varieties failing the consistency evaluation will no longer be used for the centralized drug procurement and other aspects; where there are less than three such drug manufacturers, the drug varieties passing the consistency evaluation will be given priority in the procurement and use. Efforts shall be made to accelerate the development of payment standards for drugs covered by the medical insurance by the generic name and form an incentive mechanism favorable to the use of generic drugs that have passed the consistency evaluation as soon as possible.
3. Advancing the pilot program for the drug marketing authorization holder system in an orderly manner. The drug marketing authorization holder system shall be first tried for new drugs to be marketed upon approval and drugs that have passed the consistency evaluation, so as to encourage the research and development of new drugs and facilitate the matching between new products or technology and the existing capacity. The relevant authorities shall timely sum up the experience from the pilot program, and improve relevant policies and measures, striving to advance the pilot program nationwide as soon as possible.
4. Strengthening the supervision of drug production quality and safety. The relevant authorities shall urge enterprises to strictly implement the Good Manufacturing Practice of Medical Products (GMP) and faithfully record all the information on the production process to ensure that the data is authentic, complete, accurate, and traceable; strengthen the supervision and inspection of the compliance with the GMP by drug manufacturers, release the inspection results to the public, and take timely measures to control risks.
......
Guo Ban Fa [2017] No.13
January 24, 2017
People's governments of all provinces, autonomous regions and municipalities directly under the Central Government, as well as all ministries and commissions of and all institutions directly under the State Council,
In order to deepen the medical and health system reform, improve the quality and efficacy of drugs, regulate the activities of drug circulation and use, better meet the people's requirements for medical advice and treatment, and promote the building of a healthy China, upon approval of the State Council, the following opinions are hereby set out with respect to the further reform and improvement of the policies on drug production, circulation and use:
I. Improving the Quality and Efficacy of Drugs and Promoting the Restructuring of the Pharmaceutical Industry
1. Tightening the evaluation and approval of drug marketing. New drug review shall focus on the clinical value, and generic drug review shall be conducted in the principle that the generic drug in question has the quality and efficacy consistent with that of the brand-name drug. Efforts shall be made to enrich the resources for evaluation, strengthen the guidance for enterprises' research and development, and establish an effective mechanism for ex-ante communication with the applicants, so as to accelerate the settlement of backlog in respect of drug registration applications; optimize the drug evaluation and approval process, and speed up the evaluation and approval of new drugs and medicines in shortage for urgent clinical needs; learn from the advanced international experience, explore the conduct of evaluation and approval by classes including drugs for rare diseases, pediatrics, the elderly and emergency rescue (treatment), as well as traditional Chinese medicines (classical prescriptions), and guarantee the satisfaction of the demands for medicines for the children, the elderly and other populations as well as for prevention and treatment of serious diseases. In respect of any patented drug required for the prevention and treatment of a serious disease, compulsory licensing may be enforced according to the law where necessary. It is imperative to strengthen the verification of clinical trial data and severely punish any data fraud; and fully disclose the information on drug evaluation and approval, and strengthen social supervision.
2. Accelerating the progress in the consistency evaluation for quality and efficacy of generic drugs already available on the market. Drug manufacturers are encouraged to voluntarily purchase reference preparations in accordance with relevant guidelines and reasonably select evaluation methods to carry out research and evaluation. With respect to any reference preparation to be imported, the relevant authorities shall accelerate the approval of import to improve the efficiency of customs clearance. Bioequivalence tests shall be subject to filing management, and qualified medical institutions, universities and colleges, research institutions and other social organizations engaged in testing and inspection are allowed to conduct bioequivalence tests for the consistency evaluation, with the specific implementing measures developed separately. Food and drug regulatory authorities and other departments shall strengthen the guidance on the enterprises to facilitate the completion of the tasks for the consistency evaluation as scheduled. Any drug passing the consistency evaluation will be announced to the public in a timely manner and included in the list of drugs that can be mutually substituted for brand-name drugs. Where there are three or more drug manufacturers for the same drug varieties that have passed the consistency evaluation, the drug varieties failing the consistency evaluation will no longer be used for the centralized drug procurement and other aspects; where there are less than three such drug manufacturers, the drug varieties passing the consistency evaluation will be given priority in the procurement and use. Efforts shall be made to accelerate the development of payment standards for drugs covered by the medical insurance by the generic name and form an incentive mechanism favorable to the use of generic drugs that have passed the consistency evaluation as soon as possible.
3. Advancing the pilot program for the drug marketing authorization holder system in an orderly manner. The drug marketing authorization holder system shall be first tried for new drugs to be marketed upon approval and drugs that have passed the consistency evaluation, so as to encourage the research and development of new drugs and facilitate the matching between new products or technology and the existing capacity. The relevant authorities shall timely sum up the experience from the pilot program, and improve relevant policies and measures, striving to advance the pilot program nationwide as soon as possible.
4. Strengthening the supervision of drug production quality and safety. The relevant authorities shall urge enterprises to strictly implement the Good Manufacturing Practice of Medical Products (GMP) and faithfully record all the information on the production process to ensure that the data is authentic, complete, accurate, and traceable; strengthen the supervision and inspection of the compliance with the GMP by drug manufacturers, release the inspection results to the public, and take timely measures to control risks.
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