To encourage the structural adjustment to, and technological innovations in, the drug and medical device industries so as to enhance competition in the industry and meet the clinical needs of the public, the General Office of the CPC Central Committee and the General Office of the State Council released the Opinions on Deepening the Reform of the Evaluation and Approval System to Encourage Innovation of Drugs and Medical Devices (hereinafter, the “Opinions”) on October 8, 2017. Carrying milestone significance in the innovation and development of the pharmaceutical industry, the Opinions contain six main measures as summarized below:
- The first measure pertains to the reform of clinical trial administration. The Opinions state that changing the qualification assessment of clinical trial institution under recordation-based administration and supporting clinical trials by such institutions and their personnel will contribute to improved activity of clinical trial researchers. In addition, the approval procedure for clinical trials will be optimized with the establishment of comprehensive communication and exchange mechanisms for registration applicants and evaluation agencies. Also, offshore clinical trial data will be accepted, and extended clinical trials will be supported. Meanwhile, the mechanism of the institutional review board will be improved with enhanced ethical review efficiency, and data falsification will be seriously investigated and punished.
- Acceleration of market launch evaluation and approval. The Opinions encourage accelerated evaluation and approval for the market launch of drugs and medical devices that are direly needed for clinical trials and will give priority to drugs and innovative medical devices supported and recognized by special national projects and focused research and development plans. In addition, the research and development of drugs and medical devices for rare diseases are supported, and the National Health and Family Planning Commission will announce a list of rare diseases and establish a rare disease patient registration system. Drug injections will be subject to strict evaluation and approval; if oral agents or muscular injections can meet clinical trial needs, injections deliveries will not be approved for market. Application for formulation changes between injections without obvious clinical advantage will not be approved. Linked review of drugs, drug excipients and packaging materials is conducted. The active pharmaceutical ingredients, drug excipients and packaging materials which have been subject to linked review as well as their quality standards will be announced in a designated platform for relevant enterprises to choose from. A system where compulsorily licensed patented drugs are evaluated and approved on a prioritized basis will be established.
- Drug innovation and the development of generic drugs will be promoted. The Opinions specifically set up an index of drugs on the market with all sorts of information for the drug listed. There will be efforts to create a pharmaceutical patent linkage system where appropriate compensation for specific new drugs is piloted, improve and implement the protection system for drug-related trial data so that during the period of protection, no other applicant may apply for market launch of the same product. The development and production of generic drugs are promoted to improve public access.
- The life cycle management of drugs and medical devices will be enhanced. The Opinions will promote the full-scale implementation of a market launch authorization holder system to set out the legal responsibilities of the holder and establish a system for the holder to directly report adverse effects or incidents, carry out re-evaluation of drug injections, and improve the re-evaluation system for medical devices. The Opinions regulate the promotion of pharmaceutical-related studies in academia, and a list of medical representatives that are responsible for such promotion and the promotional activities involved shall be submitted for recordation and disclosed to the public.
- Technical support capabilities will be enhanced. The Opinions require a comprehensive technical evaluation system and institution, enhanced building of evaluation and inspection capabilities, organization of professional inspector teams, implementation of the confidentiality obligation for relevant personnel and their responsibility for the entire inspection process, and strengthened international cooperation.
6. Implementation of enhanced organization structure. The Opinions stress the need to enhance organizational leadership with improved coordination and collaboration between relevant departments, with the proper announcements and explanations made.