MAH Responsibility


MAH responsibilities elucidated in China GVP

China GVP predominantly emphasizes the responsibilities of the Marketing Authorization Holder (MAH), as a substantial portion of its articles are dedicated to the comprehensive obligations.
1. China Good Pharmacovigilance Practice Announcement of the NMPA on the Publication of China Good Pharmacovigilance Practice (No. 65 of 2021)

Local Representative of Overseas MAH

The NMPA published Interim Provisions for the Administration of Local Representatives of Overseas Marketing Authorisation Holder as the guidance provision for Local Representative of Overseas MAH.
Basic requirements for becoming a MAH local representative
Based on the relevant requirements of the Drug Administration Law and the Interim Provisions,we have sorted out the two basic requirements for foreign holders to appoint domestic agents: corporate legal person and legal responsibility.
  • An enterprise legal person established in China. It can be a subsidiary, but not a branch, not a branch of a foreign company set up in China.
  • Legal liability: Article 136 of the Drug Administration Law If the holder of a drug marketing licence is an overseas enterprise, and its designated enterprise legal person in China fails to fulfil the relevant obligations in accordance with the provisions of this Law, the provisions of this Law concerning the legal liability of the holder of the drug marketing licence shall apply: i.e. civil liability, administrative liability, criminal liability, etc.

Liability as a MAH local representative
The new Drug Administration Law and the Interim Provisions further clarify the responsibility for quality and safety throughout the life cycle of a drug. The liability is borne by the MAH local representative
At present, large multinational pharmaceutical companies have set up their head offices outside of China, and one or more branch companies are usually responsible for registration, commercial representation, and pharmacovigilance representation in China, while small and medium-sized overseas pharmaceutical companies usually perform the above-mentioned duties through pharmaceutical business enterprises in China. According to the “Drug Administration Law” and the “Interim Provisions” requirements, the overseas MAH can only appoint a representative to perform its duties, which requires the domestic agent for registration, production, distribution, quality, customs, pharmacovigilance and a series of performance of the integration, and its responsibility for the entire process in the territory.
The relationship between the two is reflected in the obligations to be performed by the ” MAH local representative “
1. Responsible for establishing a drug quality assurance system to ensure that it has continuous quality assurance and risk control capabilities. Enterprises need to develop a quality assurance system document that meets their business needs and can be effectively implemented to cover the entire life cycle of the agent’s medicines.
2. Responsible for establishing and implementing a drug traceability system and providing traceability information in accordance with regulations to ensure that the whole process of the relevant listed drugs can be traced. The regulatory authority has made it clear in 2018 that it will take the lead in establishing a drug information traceability system for key varieties such as vaccines, narcotic drugs, psychotropic drugs, easily controlled chemical drugs and blood products, and has pointed out in 2020 that it will basically achieve traceability of key varieties by 31 December 2020. Domestic agents are required to establish a drug traceability system, and according to the general principle of “one item, one code, one code, one trace”, they can build their own traceability system or commission a third party technical institution to build one, and assign a unique traceability mark to all levels of drug packaging units in accordance with the unified drug traceability code requirements. For overseas MAHs, how and where to assign the code, the assignment of the code to the overseas production plant or the assignment of the code in the free trade zone, the printing requirements of the traceability code and the display of the traceability code consumer query results are topics that need to be discussed separately.
3. responsible for the establishment and can implement the drug annual report system, on behalf of the overseas holder will be confirmed by the overseas holder each year after the relevant drug production and sales in China, post-marketing research evaluation, risk management and other information in accordance with the provisions of the provincial drug supervision and management department where the agent is registered. The NMPA has recently issued the Regulations on the Administration of Annual Reports of Pharmaceutical Products, in which it is clarified that “if the holder is an overseas enterprise, the enterprise legal person (domestic agent) designated by it in accordance with the law to assume joint and several responsibilities in China shall perform the annual reporting obligations”. At present, the State does not specify the agency filing requirements for domestic agents, but the Regulations on the Administration of Annual Reports of Pharmaceutical Products show that the holder of an overseas listing permit can designate a domestic corporate legal person to fill in the information, and the corporate legal person has to bind the drugs held by the overseas listing permit holder, and a drug can only be bound by one domestic agent, and if there is a change in the agency, the original corporate legal person has to unbind the drug and unbind the new domestic agent. If there is a change in the agency practice, the original corporate entity will have to unbind the medicine and the new MAH Local representative will be re-bound. The basis for the binding is the submission of proof of agency status by the MAH Local representative, such as the enterprise information and power of attorney of the unit.
4. Responsible for the establishment of a post-marketing change management system for pharmaceutical products and for handling changes in strict accordance with the regulations. In January 2021, the S The NMPA issued the “Measures for the Administration of Post-marketing Changes to Medicines (for Trial Implementation)”. In the requirements for reporting information, it can be understood that if a drug is manufactured outside China and the overseas holder appoints an enterprise in China to act as MAH local representative for the relevant drug registration matters, it should provide a power of attorney and notarized and certified documents with Chinese translation, as well as a copy of the business license of the registered representative in China.
5. Undertake matters such as post-marketing recall, quality complaint handling and quality compensation of drugs, and report to the provincial drug supervision department where the representative is registered as required. According to the Measures for the Administration of Drug Recalls (Draft for Public Comments), which was again made available for public consultation in 2021, in relation to the recall of drugs manufactured outside China involving implementation within the country, the designated. enterprise legal person within China shall organise the implementation in accordance with the provisions of the Measures. In the case of a drug recall implemented outside China only that does not involve a domestic drug variety or batch, the designated corporate entity in China will report the recall information to the drug regulatory authority. And the designated domestic corporate entity will carry out the website publication of the recall information and act as the recipient of the service of the recall order notice.
6. It is responsible for establishing a pharmacovigilance system, formulating a post-marketing risk management plan for drugs, and carrying out monitoring, identification, assessment and control of post-marketing adverse drug reactions and other harmful reactions related to drug use as required. MAH local representative is required to establish and carry out pharmacovigilance quality systems and activities within their enterprises in accordance with the Pharmacovigilance Quality Management Code and the Pharmacovigilance Inspection Guidelines. As a domestic agent, you can carry out pharmacovigilance work on your own or commission pharmacovigilance-related work according to the actual situation of your company. It is required to have the ability to collect information on drugs outside of China and to promptly report the suspension of sales, use or withdrawal of drugs from the market due to safety reasons.
7. Responsible for submitting standard substances to the China Academy of Food and Drug Administration in accordance with  relevant regulations, and accepting sampling tests organised and carried out by the drug regulatory authorities. When the drug agent accepts the sampling and testing requirements of the drug regulatory authorities, the domestic agent is responsible for submitting the standard substances and cooperating with the relevant work.
8、Responsible for liaising with the overseas holder and cooperating with the drug regulatory authorities to carry out inspections, investigations and investigation of violations of the law at the production site of the overseas holder. In summary, as a domestic agent, there will be multiple identities in the act of representation, which may be both the customs service provider of the represented pharmaceutical product, the domestic sub-package manufacturer of the represented pharmaceutical product, or its domestic business distribution enterprise. Regardless of the identity, as a domestic agent itself, you need to have comprehensive quality assurance capabilities, as well as the ability to perform under different regulatory areas, and even if you outsource some of the functions, you need to have the ability to manage the third party entrusted to you in order to control the risks and achieve mutual benefits for both parties.

1. Public consultation request for “Interim Provisions on the Administration of Local Representative for Overseas Marketing Authorisation Holder” by the General Department of the NMPA
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