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Guidelines for Further Reform Registration Reviewing and Approval


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 Management Reformation

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.

  • The detailed policy of managing clinical trial institutions should be made and released by CFDA and China National Health and Family Planning Commission (NHFPC).
  • The main researcher in a clinical trial should be in a senior position and have participated in more than 3 clinical trials.
  • Registration applicants can ask a third party to evaluate the clinical trial institution
  • Encourage investing in clinical trial institution establishment.

Accepting Oversea Clinical Trial Data

  • The qualified data from oversea multi-center clinical trials can be used in CFDA registrations. Applicants should provide racial differences clinical data as well.
  • Oversea companies and research institutions are allowed to carry out new drug clinical trials in China

Improving IRB System and the Efficiency of Ethical Reviewing

  • For multi-center clinical trials in China, the leader of the IRB should complete the ethical reviewing and other teams should accept the results to avoid duplicate ethical reviewing.
  • National Clinical Research Center and clinical trial centers that are responsible for national science and major technology projects and national key R&D supporting projects should establish ethical reviewing platforms.

 Shortening the Approval Time of Clinical Trial Protocol

  • Clinical trials can proceed if the CFDA did not give any feedback within a preset time (not determined yet).

Encouraging Medical Devices/Drugs Innovation

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

  • Orpah drugs, clinically urgent and needed drugs could get approval with additional conditions
  • Conduct related reviews on drug and its raw material, accessories, as a package instead of individual reviews

Strength innovation rights protection

  • Establish drug patent listing system
  • Carry out the compensation pilot in drug patent period
  • Improve drug data protection
  • Establish listing drug catalog

Clarify the responsibility of the listing license holder

  • CFDA is carrying out a pilot for listing license holder system. Listing license holder will hold intellectual property (IP) and directly report adverse reaction in the future

Improving CFDA Technical Supporting Capability

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