CFDA Employees Face Prosecution for Breaching Confidentiality on Drug and Medical Device Testing

Any employees of the China Food and Drug Administration (CFDA) who breach confidentiality with regard to any information they have become privy to during the course of conducting their duties will now be liable to prosecution. This new regulation has been introduced to protect the rights and interests of any individuals / companies that apply to register drugs or medical devices for use on the mainland.

The ruling applies equally to all members of staff employed by the CFDA or any of its subsidiaries, including those responsible for registration application acceptance, technical evaluation, on-site inspection, registration testing and administrative approval. It also extends to any and all experts participating in the review and approval process.

These new requirements are outlined in the recently-published Administrative Measures of the CFDA on the Non-Disclosure of Information on the Review and Approval of Drugs and Medical Devices. The new measures took effect as of 2 June 2017.

For further details (in Chinese), please refer to the following website:

Administrative Measures of the CFDA on the Non-Disclosure of Information on the Review and Approval of Drugs and Medical Devices