New Chinese Device and Drug Regulations Issued on October 8, 2017

China regulations for medical registration could be easing soon. On October 8, 2017, new regulations from the State Council were issued. The proposed changes are not yet law.

For both drugs and devices, the proposed changes will include:

  1. Acceleration of the CFDA Review and Approval Timeline: Contrary to the CFDA’s 2014 announcement, foreign clinical trial data for drugs and devices will now be accepted. This allows global CROs to support local Chinese clinical research sites. Data must be collected from trials conducted at multiple centers, and must meet the CFDA’s registration regulations. For Western medical device manufacturers, reducing the need for local clinical trials for product approvals will lower the cost of market entry.
  • In addition, the CFDA plans on increasing clinical trial resources. Currently, only 600 of around 100,000 medical                institutions are certified to conduct clinical trials. To remedy this issue, the CFDA plans on removing the certification system. Instead, manufacturers will be held responsible for recruiting third parties to conduct trials. The CFDA will also promote trials by implementing quality systems and incentives for medical staff and scientists.
  1. Improvements of the CFDA Review and Approval System: The CFDA has announced several reforms to optimize the review and approval process. These changes include the establishment of a centralized dossier system, the establishment of a panel review system, the utilization of more efficient communication channels, etc.
  2. Implementation of the Marketing Authorization Holder system: For all major aspects of the product life cycle (research and development, clinical trials, sourcing and manufacturing, distribution, recalls, and adverse events, etc.) device and drug manufacturers must appoint a marketing authorization holder (MAH) to be held responsible for both pre- and post-approval activities.
  3. Strengthen Intellectual Property (IP) Protection: Historically, the CFDA has implemented very few regulations to protect IP, and IP theft has been rampant amongst Chinese manufacturers. How China and the CFDA will enforce better IP protection is still unclear.