China to stipulate the accountabilities of Marketing Authorization Holder (MAH)

China released the “Revision of the Drug Administration Law of the People's Republic of China” for public comment

The Revision highlights the accountabilities of MAH:

1) MAH is held accountable for the pre-clinical and clinical trials, manufacturing and distribution, post-marketing research, as well as monitoring, reporting and follow-up of adverse events (AEs).

2) MAH needs to establish a Quality Management System (QMS) and appoint an independent responsible quality management personnel.

3) MAH needs to sign agreements with third party service providers that are involved in the drug manufacturing, distribution, storage and shipment to ensure these service providers have the robust capabilities of quality assurance and risk management.

4) MAH needs to implement risk management actions for drugs approved with conditions and complete the related studies by the pre-defined timeline.

5) MAH can license out the drug registration certificate and specify receiver’s obligations.

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