In China, pharmaceutical companies or research institutes with drug registration certificates are drug marketing authorization holders (MAHs). According to the Drug Administration Law, marketing authorization holders should assume the responsibilities for drug safety, efficacy and quality controllability during the entire life cycle covering R&D, manufacturing, supply, and use.

To better help international marketing authorization holders with regulatory compliance in China, BaiPharm publishes this article to answer the following questions:

• What are the obligations of drug marketing authorization holders?
• Should overseas marketing authorization holders appoint a Chinese agency?
• What are the marketing authorization holder agency\’s responsibilities?
• What agency services can BaiPharm offer to overseas marketing authorization holders?

Obligations of Drug Marketing Authorization Holders 

Marketing authorization holders shall be responsible for nonclinical research, clinical trial, manufacturing and sale, post-marketing research, as well as adverse drug reaction (ADR) monitoring, reporting and handling as per the Drug Administration Law. Overseas MAHs shall appoint a legal corporate entity in China to fulfill the responsibilities on their behalf. The overseas MAH and the Chinese agency shall take joint liability. 

MAHs\’ detailed obligations include the following items:

• Establishing a drug quality assurance (QA) system, with professionals independently taking the responsibility of quality assurance;
• Periodically inspecting the quality management systems of the entrusted manufacturers and distributors in the downstream supply chain; supervising them to ensure sustainable quality assurance and control;
• Establishing a marketing release protocol for the manufactured drugs; auditing the drug products before they enter the market; releasing the pharmaceuticals to the market only with the quality manager\’s signature;
• Establishing and implementing a drug traceability system;
• Establishing an annual report* system; submitting drug information to provincial medical products administrations.

*MAH annual report should cover drug\’s manufacturing, sales, post-marketing researches, and risk management in each calendar year.

A report shall cover two parts of information:

Part 1: General Information:

• The MAH\’s information (name, registered address, etc.);
• General information of the products owned by the MAH;
• Summary of quality management;
• Establishment and performance of the pharmacovigilance system;
• Manufacturing tasks entrusted by overseas company (this item only applies to Chinese MAHs);
• Inspections conducted by overseas regulator for the MAH.

Part 2: Product information:

• The product\’s basic information;
• Manufacturing and sales;
• Post-marketing research and variation (changes of MAH, manufacturing sites, etc.) management;
• Risk management.

Each annual report should be written according to NMPA\’s Drug Annual Report Template. In principle, an MAH should submit one report annually, which covers all the products owned by the MAH.

The 2021 annual report should be submitted to the Drug Annual Report Collection Module before August 31, 2022. The subsequent annual reports should be submitted before April 30 of the following year. For example, the 2022 annual report\’s submission should be made before April 30, 2023.

If failing to submit the report in time, the MAH will receive a warning from NMPA. If continuing the wrongdoing after the warning, the MAH will even be subject to 100,000-500,000 yuan fines.

Obligations of Overseas Marketing Authorization Holders\’ Chinese Agency

According to the consultation draft of Interim Administrative Rules on Domestic Agencies for Overseas Drug MAHs, Chinese agencies shall perform the following responsibilities:

• Establishing a drug quality assurance system and ensuring its sustainable quality assurance and risk control capabilities;
• Establishing and implementing a drug traceability system; providing traceability information and ensuring the traceability of the relevant marketed drug during its entire life cycle;
• Establishing and implementing the annual drug report system; annually reporting on behalf of the overseas MAH about the relevant drug\’s manufacturing, sales, post-marketing research & evaluation, and risk management in China after all the information is confirmed by the overseas MAH; submitting the report to the provincial medical products administration of the provincial-level administrative region where the agency was registered;
• Establishing the management system for post-marketing changes; carrying out matters related to drug changes according to regulations;
• In the post-marketing stage, undertaking product recall, quality complaint handling, quality compensation, etc., and reporting to the provincial medical products administration of the provincial-level administrative region where the agency was registered;
• Establishing a pharmacovigilance system; formulating post-marketing risk management plans; monitoring, identifying, assessing and controlling post-marketing adverse drug reactions and other adverse reactions related to drug use;
• Submitting reference substances to the China National Institutes for Food and Drug Control; accepting random inspection by medical products administrations;
• Liaising with the overseas MAH; coordinating with the medical products administration to inspect and investigate overseas manufacturing site, as well as dealing with possible violations of laws and regulations. (Official Notice)

BaiPharm Offers Marketing Authorization Holder Agency Services

BaiPharm can serve as a Chinese agency of overseas MAHs to fulfill all the obligations mentioned in Part 2 of this article. BaiPharm also provides Good Supply Practice (GSP) audit and pharmacovigilance audit. Contact BaiPharm if you need professional regulatory services supported by senior experts.

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