On October 8, in a government news conference in Beijing, the State Council issued the “Opinion on Encouraging the Innovation of Drugs and Medical Devices by Deepening the Reform of Review and Approval System (hereinafter referred to as “Opinion”).
This is another programmatic document about deepening the reform of review and approval system of the drug and medical devices, which has become a new milestone of the innovation and development of China’s pharmaceutical industry after the “China’s State Council: Official Opinions On Deepening the Review and Approval Policies Reform and Encouraging Drug And Medical Device Innovations” was issued by the State Council in August 2015.
In this post, we at China Med Device (CMD) gives Highlights of this milestone document and we plan to follow up with more detailed information about this initiative.
At present, many favorable conditions can be used to encourage the innovation of drug and medical device. First, domestic pharmaceutical innovation is surging. Second, the reform of review and approval system is progressing smoothly. The reform of review and approval system of drug and medical device started in 2015 improved the quality and standard of the review and the transparency of the review and approval. The backlog problem of drug review has been solved timely. Third, the therapeutic effect evaluation of quality and efficacy consistency of imitative drugs starts smoothly. Fourth, the medicament license holder system has made smooth progress in ten pilot provinces and cities, which inspired the innovation passion of scientific research personnel.
The “Opinion” proposed 6 parts of a total of 36 reform measures, including reforming the clinical trial management, speeding up the review and approval of medicament license, promoting the innovation of drug and medical device and the development of imitative drugs, strengthening the life cycle management of drug and medical device, enhancing the technical support capacity, and strengthening the organization and implementation to solve the prominent problems on the innovation of current drug and medical device and establish a long term system construction.
The “Opinion” proposed to change the qualification recognition of clinical trial agency to filing management to solve the shortage problem of clinical research resources, and support clinical trial agencies and personnel to carry out clinical trials. In order to meet the use of urgent need clinical medical device, the “Opinion” proposed to speed up the review and approval of clinical urgent need drug and medical device, allow the medicament license approval with attached conditions that supplementary research will be carried out after the products appear in the market. In order to enhance the accessibility of medical device for patients of rare disease, the “Opinion” supported the development of medical devices and drugs for rare diseases, and the relevant drugs and medical devices that have been approved to enter the market abroad can be approved for market-entering on attached conditions.
In order to furtherly promote the therapeutic effect evaluation of quality and efficacy consistent of imitative drugs, the “Opinion” requested to establish the catalog collection of drugs which will appear in China’s market, and all the drug information should be indicated. The “Opinion” also proposed to explore and establish the drug review and approval system, the drug patents link system, the patent term compensation system, the clinical data protection system and more, and promote the full implementation of the medicament license holder system. The medicament license holder should be responsible for the research and development of drugs and medical devices, clinical trials, manufactures, sales and distributions, and adverse reaction reports. The “Opinion” required to improve the technical review system, strengthen the building of review and inspection capacity, and establish professional inspector teams.
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