The General Office of the CPC Central Committee and the General Office of the State
Council issued the Advice on Deepening the Reform of Review and Approval System
and Encouraging the Innovation in Drugs and Medical Devices
Recently, the General Office of the CPC Central Committee and the General Office of the State Council issue the Advice on Deepening the Reform of Review and Approval System and Encouraging the Innovation in Drugs and Medical Devices and ask the local governments to implement such advice in combination with reality.
The full text of the Advice on Deepening the Reform of Review and Approval System and Encouraging the Innovation in Drugs and Medical Devices is as follows.
The drug & medical device industry in China is developing rapidly, the innovation & entrepreneurship is in the ascendant and the examination and approval system reform is continuously promoting. However, in general, the scientific innovation of drugs & medical devices is not well supported in China, and the marketed products are not as good in quality as the international advanced level. In order to promote the industrial restructuring and technical innovation of drugs and medical devices, improve the industrial competitiveness and meet the clinical demands of the public, we make the following advices on deepening reform of examination and approval system and encouraging innovation in drugs and medical devices.
I. Reform the clinical trial management
1. The clinical test facilities are subject to record management for qualification. 2. Support the clinical test facility and personnel to carry out clinical trials. 3. Complete the ethic committee mechanism. 4. Improve the ethical review efficiency. 5. Optimize the clinical trial approval procedure. 6. Accept the overseas clinical trial data. 7. Support expanding clinical trials. 8. Investigate and treat the data fraud.
II. Accelerate marketing evaluation and approval
9. Accelerate the evaluation and approval of drugs and medical devices in urgent clinical need. 10. Support R&D of drugs and medical devices for rare diseases. 11. Strict in examination and approval of drugs and injections. 12. Link approval of drugs and medicinal raw and auxiliary materials and packaging materials. 13. Support TCM inheritance and innovation. 14. Establish priority examination and approval system for patent compulsory licensed drugs.
III. Facilitate drug innovation ans generic drug development
15. Establish a directory of marketed drugs. 16. Explore and establish drug patent link system. 17. Make pilot system for drug patent term compensation. 18. Complete and implement drug test data protection system. 19. Facilitate generic drug production. 20. Play the leading role of enterprise for innovation. 21. Support clinical application of new drug.
IV. Strengthen the full life cycle management of drugs and medical devices
22. Promote the full implementation of marketing license holder system. 23. Implement the legal responsibility of the marketing license holder. 24. Establish a system for the marketing license holder to report adverse reactions and adverse events directly. 25. Re-evaluate the drugs and injections. 26. Complete the reevaluation system for medical devices. 27. Standardize the academic drugs promotion behavior.
V. Improve the technical support capability
28. Complete the technical evaluation system. 29. Implement the confidentiality responsibility of relevant staff. 30. Strengthen the capacity building of evaluation and examination. 31. Implement the inspection responsibility throughout the process. 32. Establish a team of inspection professionals. 33. Strengthen international cooperation.
VI. Strengthen organization and implementation
34. Strengthen the organizational leadership. 35. Intensify cooperation and coordination. 36. Complete publicity and interpretation.