On October 8th, China State Council released guidelines for Further Reform Registration Reviewing and Approval to encourage medical device/drug innovation for comments. The guidelines contain 36 provisions for 6 key areas, which are:
1) Reform clinical trial administration
2) Accelerate regulatory reviewing and approval
3) Encourage drug innovation and generic drug development
4) Strengthen the whole life cycle of management of medical devices/drugs
5) Enhance technical support capacity
6) Improve policy implementation
In 2015, the State Council started the reform releasing guidelines for reform registration reviewing and approval of medical devices/drugs. From 2015 to 2017, the State Council and CFDA have released a batch of new policies to accelerate the timeline of medical device/drug approval. This new set of guidelines mainly focuses on solving the problems that emerged in the last 2-years of reformation and improving the R&D of innovative drugs and medical devices–to further consolidate the market.
Clinical Trial Site Filing System
In China, although there are more than 2000 3A+ medical institutions, there are only 600 institutions that are qualified and approved to conduct clinical trials for drugs. Specifically, there are only 100+ institutions that can handle Phrase I clinical trials. The available clinical trial institutions cannot meet the needs of medical device/drug innovations. For this reason, China State Council released the clinical trial site filing System to replace the old clinical trial qualification system.
Accepting Oversea Clinical Trial Data
Improving IRB System and the Efficiency of Ethical Reviewing
Shortening the Approval Time of Clinical Trial Protocol
In 2014, the CFDA released “Green Pathway for Innovative Medical Device (Draft)” and opened a fast track for innovative medical device approval. Until now, the CFDA has received over 100 applications and approved 29 innovative products. In 2016, the CFDA released “Medical Device Priority Approval Process” to include 8 products (for children, elders, orphan diseases, etc.) as priorities for the approval process. In this guideline, the CFDA released more policies to further encourage innovation of medical devices/drugs.
Speed up medical device/drug listing review and approval
Strength innovation rights protection
Clarify the responsibility of the listing license holder
Improving CFDA Technical Supporting Capability