A Local Agent in China is legal representative of overseas pharmaceutical and medical devices companies required as per the NMPA regulations. The Local Agent is responsible for the safety, efficacy, and quality control of the whole process of the production, operation, and use of its licensed drugs and devices in China. The overseas company is required to appoint a local agent before any regulatory interactive or filing activities in China.
The Local Agent: The term “agent” refers also to a legal person or local representative, of a domestic enterprise in China who has obtained a certificate of drug registration in China and is designated by law to perform the obligations of an overseas marketing authorization holder in China.
General Requirements for Local Agent in China To be considered as Local Agent (local Representative) of foreign pharmaceutical and medical device companies in China.
Local Agent should have:
1. Legal Person
A legal person of the Company located in China
2. Quality Management System
Have in place the appropriate Quality Management System that can support the agent work and can support its responsibilities
3. Office Space
Have the appropriate office space, work environment, contact information, phone number to be able to perform the tasks that are required.
4. Product Traceability
Have a management system that ensures product traceability.
Responsibilities of Local Agent in China
- Responsibilities of Local Agent in China
- Establishing and implementing a quality management system for drug traceability
- Establishing and implementing an annual report system for drugs and reporting them to the provincial or national health agency, where the agent is registered
- Performing recalls of drugs, handling quality complaints, and reporting them to the provincial or national health agency where the agent is registered.
- Information to be reported: annual production and sales, post-marketing research and evaluation
- Establishing a drug alert system, formulating a post-market drug risk management plan, and carrying out monitoring, identification, evaluation and control of adverse drug reactions and other harmful reactions related to the drug use as required.
- Submitting standards to the China health agency for audit and inspection by health agency.
- Being the liaison with the overseas holder
Supervision and Inspection of Local Agent in China:
- Provincial Drug Administration is responsible for the supervision and inspection of local agents.
- Inspections are conducted by two inspectors, and the inspecting persons shall provide legal documentation to the company being inspected.
- The inspectors will maintain confidentiality of any business information of the company that they have obtained during the inspection
GRP can act as your local Agent in China, Contact our team today to Inquire!
- Contact Us – Global Regulatory Partners, Inc.
- Email: email@example.com
- Telephone : (+1) 781-672-4200
The comprehensive department of the state food and drug administration publicly solicited opinions on the interim provisions on the administration of domestic agents of overseas drug marketing authorization holders (draft for solicitation of comments). (nmpa.gov.cn) 2020-08-03. For the link, click here (Only available in Chinese).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.