On November 29, 2019, NMPA issued the Announcement on Issues Pertaining to the Implementation of the Drug Administration Law of the People's Republic of China (2019 No. 103), which reads as follows:
Revised and adopted by the Twelfth Session of the Standing Committee of the 13th National People's Congress on August 26, 2019, the revised Drug Administration Law of the People's Republic of China (hereinafter referred to as DAL) shall be implemented as from December 1, 2019. NMPA is stepping up work on the development, formulation and revision of supporting regulations, normative documents and technical guidelines, which will be released in accordance with procedures. We hereby announce the issues pertaining to the implementation of the newly revised DAL as follows:
I. The Drug Marketing Authorization Holder System
The newly revised DAL takes the drug marketing authorization holder (MAH) system into full swing. Starting from December 1, 2019, all undertakings or drug R&D institutions holding drug registration certificates (drug approval numbers, import drug registration certificates, or medical product registration certificates) shall be taken as drug MAHs, who should strictly perform their corresponding obligations, and take responsibility for drug safety, effectiveness and quality controllability in the whole process of drug R&D, production, distribution and use.
II. Record-filing management of clinical trial institutions
As from December 1, 2019, drug clinical trial institutions (DCTIs) shall be, invariably, subject to record filing management. DCTI-qualification applications accepted before December 1, 2019, with pending examination & approval results, shall be subject to record filing per the current regulations.
III. Requirements for drug GMP and GSP administration
As from December 1, 2019, drug GMP and GSP certifications shall be cancelled, and the corresponding applications / certificates shall be no longer accepted / issued. Certification applications accepted before December 1, 2019 shall be processed in accordance with the relevant provisions of the original drug GMP and GSP certification. To applications with on-site inspection completed and conformance to requirements before December 1, 2019, drug GMP and GSP certificates can be issued. On-site inspection shall be carried out even after December 1, 2019, where the current regulations require it, and the corresponding results shall be notified to the enterprise; non-compliance found in the inspections shall be dealt with in accordance with regulations pursuant to the Law.
IV. Associated review & approval for chemical APIs
tarting from December 1, 2019, no drug registration certificate will be issued for chemical APIs, whose manufacturers shall register on the AEP (APIs, pharmaceutical excipients, packaging materials and containers in direct contact with pharmaceuticals) registration platform for associated review & approval.
V. Investigation and prosecution of drugrelated illegal activities
For illegal activities occurred before December 1, 2019 in drug R&D, production, distribution, and use, the former DAL (unrevised) shall apply, barring those deemed by the newly revised DAL as overestimated or underestimated activities, for which the newly revised DAL shall prevail. For illegal activities occurred after December 1, the newly revised DAL shall apply.
Drug regulatory authorities at all levels must resolutely implement the Four Strictest (Strictest Standards, Regulation, Punishment, and Accountabilty) Requirements for drug safety, strengthen the publicity and implementation of the newly revised DAL, further strengthen supervision and inspection, urge enterprises to continue to comply with production & distribution protocols, and strictly investigate and punish all kinds of illegal acts, to effectively safeguard medication safety for the general public.