The Advice on Deepening the Reform of Review and Approval System and Encouraging the Innovation in Drugs and Medical Devices (the Advice) was issued jointly by the General Office of the CPC Central Committee and the General Office of the State Council on October 8. It becomes another programmatic document after the Opinion of State Council on Reformation of Examination and Approval system for Drug and Medical Devices issued in August 2015 for deepening the reform of examination and approval system for drug medical devices, and a milestone for the innovation & development of the pharmaceutical industry in China.
At present, there are many advantages for encouraging the innovation of drugs and medical devices. First, the medical innovation is gigantic and vigorous in China. In recent years, the declared number of new drugs and innovative medical devices has been increasing year by year in China. Fifteen class I innovative drugs are approved for production, including Icotinib, Apatinib, Chidamide, Conbercept, and 29 innovative medical devices are approved to be launched. A batch of domestic drugs, including Risperidone Sustained Release Microsphere, Conbercept Ophthalmic Injection, are applying for registration in developed countries such as the US and EU to get into international market, and the innovative medical devices, including percutaneous heart valve prosthesis system, breast X-ray digital tomography equipment, implantable vagus stimulation pulse generator, have reached the international leading level. Second, the reform of the examination and approval system goes well. The reform of examination and approval system for drugs and medical devices since 2015 increases the examination quality and standard, cracks down the scientific fraud atmosphere and transparentizes the examination and approval system. The drug examination backlog is solved as scheduled. Third, the generic drug quality and efficacy consistency evaluation starts smoothly. In February 2016, the State Council declared the policies in special document and some local governments introduced supporting policies, and the enterprises are active in the consistency evaluation. Recently, there will be a batch of generic drugs approved. Fourth, the marketing license holder system goes well in ten provinces and cities, inspiring the scientific researchers for innovation.
There are 36 reform measures in 6 parts in the Advice concerning the prominent challenges to the innovation of drugs and medical devices for long-term system construction, including reform the clinical trial management, accelerate the marketing evaluation and approval, facilitate the drugs and medical devices innovation and the generic drugs development, strengthen the full life cycle management of drugs and medical devices, improve the technical support and intensify the organization and implementation. For the resource shortage in clinical investigation, the qualification of clinical test facility is replaced with record management in the Advice, supporting the clinical test facility and personnel to carry out clinical trials. To meet the urgent usage need of clinical drugs and medical devices, according to the Advice, the evaluation and approval of the drugs and medical devices in urgent clinical need shall be accelerated to allow conditional marketing, with supplementary researches carried out after marketing as required. To promote the availability of drugs and medical devices for patients with rare diseases, the research and development of drugs and medical devices for rare diseases is supported in the Advice, and the overseas approved drugs and medical devices can be approved for conditional marketing in China. To advance the generic drug quality and efficacy consistency evaluation, the marketing drugs directory is established in the Advice, with drug information specified. In addition, the Advice includes exploration of establishment of drug evaluation and approval and drug patent link system, patent term compensation system, clinical data protection system. According to the Advice, the marketing license holder system shall come into full implementation, and the holder shall be legally responsible for the R&D of drugs and medical devices, clinical trial, manufacturing, marketing and distribution, adverse reaction report. The technical evaluation system shall be completed, and the evaluation and inspection capacity building shall be enhanced, with a professional inspector team established. The system for deepening reform of examination and approval system is designed based on the industrial practice with the strategic perspective of pharmaceutical industry participating in international competition and increasing the people’s health, which is good for encouraging innovation, reducing low-level repetition, and meeting the clinical treatment demand, so as to facilitate the healthy development of the pharmaceutical industry.
The introduction of the policy to deepen the reform of examination and approval system to encourage the innovation of drugs and medical devices is of great significance to the implementation of the strategy of building an innovative country put forward in the 18th National Congress of the Communist Party of China, stimulation of the innovation and development vitality of the pharmaceutical industry, promotion of structural reform of supply side of the pharmaceutical industry, improvement of the domestic drugs and medical devices quality and international competitiveness, better satisfaction of the public needs, promotion of building of healthy China and safeguard of the country.