Highlights of CFDA’s Plan To Implement Review and Approval System Reform and Encourage Drug and Medical Device Innovation in China
In October 2017, China’s Central Government’s State Council promulgated The Opinions on Deepening the Review and Approval System Reform and Encouraging the Drug and Medical Device Innovation. In accordance, CFDA Director Mr. Bi Jingquan held a Videophone Conference to explain and make necessary arrangements for his agency to implement the mandatory opinions. In his speech, the CFDA Director covered three areas with the following important points:
Fully understand the importance and necessity of deepening reform and encouraging innovation:
Deepening reform and encouraging innovation is an urgent need to fulfill China’s strategic thoughts on food and drug regulation to ensure the safety and quality of drugs and medical devices.
Deepening reform and encouraging innovation is an urgent need to fulfill the public’s access to new, good, and affordable drugs.
Deepening reform and encouraging innovation is an urgent need to promote the structural reform of the supply-side in pharmaceutical industry and to fulfill the innovation-driven national development strategy.
Comprehensively understand the objectives and missions of deepening reform and encouraging innovation:
Expand resources on clinical trials
Accept clinical trial data generated abroad.
Optimize market approval procedure for drugs and medical devices.
Strengthen IP protection.
Speed up the process of quality and efficacy consistency evaluation.
Establish filing procedures for drugs and medical devices.
Place legal liabilities on the Market Authorization Holder (MAH).
Clarify regulatory responsibilities between the central and local government.
Strengthen institutional guarantees and capacity building.
Feasibly avoid conflict of interests.
Concretely implement every reform task.
Make great efforts on learning and training.
Strengthen organization and leadership.
Strengthen coordination and cooperation.
Complete associated policies.
Enhance efforts on regulatory inspection.
China Med Device thinks that the CFDA is making the right start by recognizing the importance of and planning for concrete measures to implement The Opinions. The effect of reform implementations and measures to protect overseas device manufacturers’ innovations remains to be seen. But with success even on a limited scale, this will be a quantum leap on China’s part to open its doors wider to overseas medical device companies, which in turn will help meet the growing healthcare demands of the Chinese people.
About China Med Device, LLC (CMD): CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services. If you have an inquiry or feedback regarding our services please email us at info@ChinaMedDevice.com.