MAH Domestic Agent Services

1. Become your domestic agent

2. Be your domestic contact person (written in the drug description)

3. Perform all the work that should be performed by the domestic agent

4. Complete the registration process to enter China

5. Audit overseas manufacturing plants to ensure they meet NMPA GMP requirements

6.Other related work

What is a "domestic agent"?

Domestic agent is an organization established in China by an overseas pharmaceutical company as required by the “Interim Provisions on the Administration of Domestic Agents of Overseas Drug Marketing Authorization Holders (In Trial Operation) (Draft for Comment)” to perform the obligations of the overseas pharmaceutical company as a drug listing permit holder under the laws and regulations on behalf of the overseas pharmaceutical company in China.

In simple terms, a domestic agent in China is equivalent to a MA holder set up by an overseas company in China.

What are the responsibilities of the domestic agent?

(1)Responsible for establishing a drug quality assurance system to ensure that it continues to have quality assurance capabilities and risk control capabilities;

(2)Responsible for establishing and implementing a drug traceability system, providing traceability information as specified and ensuring the traceability of related drugs marketed throughout their life cycles;

(3) Responsible for establishing and implementing a drug annual report system and, in accordance with the regulations, annually reporting, on behalf of the Overseas Holder, the production, distribution, post-marketing studies and evaluation as well as risk management of related drugs within the territory of China upon confirmation by the Overseas Holder to the provincial drug regulatory authority where the agent is registered;

(4) Responsible for establishing a post-marketing change management system and handling changes in strict accordance with regulations;

(5)Responsible for handling of post-marketing recalls, quality complaints, quality compensations, and other issues of the drug, and reporting to the provincial drug regulatory authority where the agent is registered according to regulations;

(6) Responsible for establishing a pharmacovigilance system, formulating post-marketing risk management plans for drugs and, as required, carrying out the monitoring, identification, assessment and control of post-marketing adverse drug reactions and other drug use related hazardous reactions;

(7) Responsible for submitting reference materials to National Institutes for Food and Drug Control in accordance with relevant regulations, and accepting spot checks organized and implemented by drug regulatory authorities;

(8) Responsible for contacting the Overseas Holder and cooperating with drug regulatory authorities in the inspection and investigation of manufacturing site(s) of the Overseas Holder as well as the investigation and handling of illegal acts.

The above page is from the NMPA wesite.

https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20200803190645124.html