Measures for the Supervision and Administration of Drug Production (No.28-2020) was issued by China’s State Administration for Market Regulation (SAMR) on January 22, 2020, and came into effect on July 1, 2020. In order to meet the requirements of the Drug Administration Law and Vaccine Administration Law, the measures standardize the drug production process, as well as its supervision and inspection, and implements production quality responsibility. This post is a reminder to drug manufacturers about key regulatory requirements for production of drugs marketed in China.
Measures for the Supervision and Administration of Drug Production in China – Highlights
A summary of the key points of China’s Measures for the Supervision and Administration of Drug Production has been prepared by Cisema’s regulatory experts and is set out below.
- MAH (including self-manufactured or entrusted manufacturing) shall apply for a “Drug Manufacturing License”. The APIs that have been approved or passed the related review and approval shall be produced by themselves, and shall not be entrusted to others for production.
- The drug production license is valid for five years and is divided into original and duplicate. If the drug production license expires and it is necessary to continue the production of drugs, it shall apply to the original license-issuing authority for re-issuing the drug production license six months before the expiry of the validity period.
- To change the licensing items of the drug production license, it is necessary to submit an application for the modification of the drug production license to the original license-issuing authority. If the change involves the contents of the drug registration certificate and its attachments, it shall be reported to CDE to update the relevant contents of the drug registration certificate and its attachments after approval by the drug regulatory department of the province (or autonomous region or municipality directly under the Central Government).
- MAH shall establish a drug quality assurance system, assign specialized personnel to be independently responsible for drug quality management, conduct regular audits of the quality management systems of the entrusted drug manufacturers and drug distributors, and supervise their continuous quality assurance and control capabilities.
- MAH shall establish an annual reporting system, and report the production and sales, post-marketing research, risk management, etc.
- MAH shall establish a pharmacovigilance system and carry out pharmacovigilance work in accordance with the pharmacovigilance quality management standards formulated by NMPA.
- If the MAH is an overseas enterprise, it shall designate an enterprise legal person within the territory of China to perform the obligations of a drug marketing authorization holder as stipulated in the Drug Administration Law and these Measures, and be responsible for coordinating and cooperating with overseas inspections.
- The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the supervision and administration of drug marketing license holders, products, chemical raw materials, and Chinese herbal decoction pieces within their respective administrative regions.
- Chapter 5 of these Measures also lists relevant acts related to penalties or violations of the law.
The National Medical Products Administration (NMPA) published the following regulatory documents in April 2022 concerning post-market activities of drug products in China:
- Administrative Measures for Drug Annual Reports (No.16-2022)
- Guidelines for Pharmacovigilance Inspection (No. 17, 2022)
By Yu and Jacky. If you would like to learn more about Measures for the Supervision and Administration of Drug Production or our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, industrial or consumer goods contact Cisema.