Opinions of the State Council on the Reform of Evaluation and Approval System for Drugs and Medical Devices

Opinions of the State Council on the Reform of Evaluation and Approval System for Drugs and Medical Devices

Guo Fa [2015] No.44

August 9, 2015

The people's governments of all provinces, autonomous regions and municipalities directly under the Central Government, all ministries and commissions under, and all institutions directly under, the State Council,

The quality and standards of drugs and medical devices have been improving amid the fast development of China's pharmaceutical industry in recent years, better meeting public medical needs. Meanwhile, the issues in the evaluation and approval process of drugs and medical devices are increasingly prominent. As application materials submitted for registration are usually of low quality and need to be supplemented and improved for many times in the evaluation process, the evaluation and approval efficiency is affected severely; generic drugs are developed and applied repeatedly and fall in cutthroat market competition; the quality of partial generic drugs is far from the international advanced level; the time required for the approval of marketing of new drugs in urgent clinical demand is too long; as pharmaceutical research and development institutions and researchers are prohibited from drug registration application, their enthusiasm in drug innovation is adversely affected. To this end, the opinions on the reform of evaluation and approval system for drugs and medical devices are given as follows:

I. Main Objectives
1. Raise evaluation and approval quality. It is required to establish a more scientific and efficient evaluation and approval system for drugs and medical devices to make the drugs and medical devices approved for marketing reach or approach the international advanced level in terms of efficacy, safety and quality controllability.
2. Resolve registration application backlog. It is imperative to keep a tight rein on the approval of oversupplied drugs, try to complete the backlog by the end of 2016, achieve the annual balance between the number of registration applications and evaluated cases as soon as possible, and realize the approval according to the prescribed time limit by the end of 2018.
3. Improve the quality of generic drugs. It is imperative to accelerate the quality conformance assessment of generic drugs, and try to complete the quality conformance assessment of oral preparations and reference preparations of national essential drugs by the end of 2018.
4. Encourage the research and development of new drugs. It is required to encourage clinical value-oriented drug innovation, optimize the evaluation and approval procedures for innovative drugs, accelerate the evaluation of innovative drugs in urgent clinical demand, and conduct the pilot program of the drug marketing license holder system.
5. Improve evaluation and approval transparency. It is imperative to completely publicize the conditions and the relevant technical requirements for the acceptance, technical evaluation, product inspection and on-site inspection for the registration of drugs and medical devices, make public the information relating to acceptance and approval, and guide applicants to research, develop and apply in good order.

II. Main Tasks
6. Enhance drug approval standards. Drugs are divided into new drugs and generic drugs. The definition of new drugs is adjusted from "drugs that have not been sold within the territory of China" to "drugs that have not been sold within or outside the territory of China". According to the originality and novelty of the material basis, new drugs can be divided into innovative drugs and improved drugs. The definition of generic drugs is adjusted from "imitated drugs for which the national standard has been established" to "imitated drugs with quality and efficacy consistent with the original developed drugs". Drug registration classification should be adjusted based on the above principles.
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