In 2019, the Drug Administration Law in China fully implemented the Marketing Authorization Holder (MAH) system. In 2020, the China National Medical Products Administration (NMPA), the counterpart of the US FDA and EU EMA, issued the “Interim Provisions on the Management of Local Representatives of Overseas Drug Marketing Authorization Holders (Draft for Comments).”
This article outlines the conditions, responsibilities, and supervision of Local Representatives in China, as well as the importance and obligations for MAHs to conduct regular PV audits on their local representatives in China.
Introduction to Local Representatives Policy
The Local Representatives Policy is a newly added regulation derived from the new Drug Administration Law and MAH policy. The Local representatives of overseas MAH in our country is not an agent in the sense of the civil law system, but a representative in the context of the Drug Administration Law. The establishment of Local representatives is essentially aimed at aligning with the full lifecycle management centered around the holder. Local representatives and overseas MAHs are jointly and severally liable in civil liability, and their administrative and criminal responsibilities are governed by pharmaceutical laws and regulations.
Evolution of Management of Local Representatives for Imported Drugs
When the Drug Administration Law was first implemented in 2001, the MAH policy was not in place, nor were there specific requirements for local representatives of imported drugs. In practice, overseas MAHs selected appropriate sales agents and domestic drug packaging manufacturers based on factors like product characteristics, sales strength, channel resources, academic promotion ability, and market reputation.
The comprehensive implementation of the new Drug Administration Law in 2019 and the Drug Registration Management Law in 2020 removed the distinction between domestically produced and imported drugs. For the first time, the Drug Administration Law explicitly required overseas MAHs to establish corporate legal entities within China to fulfill legal obligations and assume joint and several liability.
Requirements for China Local Representatives
In August 2020, the NMPA solicited opinions on the “Provisional Regulations on the Administration of Local Representatives of Overseas Marketing Authorization Holders.” This regulation defines Chinese domestic enterprise legal entities established by overseas holders as Local Representatives and specifies their definition, conditions, obligations, supervision, and other matters.
Conditions for China Local Representatives
Local Representatives of overseas MAHs must meet the following conditions:
- Be corporate legal entities established within mainland China.
- Possess a quality management system suitable for agency work and responsibilities.
- Have appropriate office space, communication methods, and contact phone numbers for agency work.
- Maintain a management system ensuring product traceability.
Obligations of China Local Representatives
- Establishing a drug quality assurance system.
- Implementing a drug traceability system.
- Setting up an annual drug reporting system.
- Managing post-marketing changes for drugs.
- Handling post-market drug recalls, quality complaints, and quality compensation.
- Establishing a pharmacovigilance system.
- Submitting drug standard substances.
- Maintaining contact with overseas holders.
- Ensuring compliance with Good Pharmacovigilance Practices (GVP).
MAH Responsibilities for Auditing China Local Representatives
To ensure compliance with Chinese regulatory requirements, MAHs must audit their Local Representatives regularly. This includes verifying the Local Representatives’ adherence to GVP, quality management systems, and pharmacovigilance obligations. Regular audits help maintain high standards of drug safety and effectiveness, ensuring that Local Representatives fulfill their responsibilities effectively.
In May 2022, the NMPA solicited opinions on the “Implementation Regulations of the Drug Administration Law,” which covered the appointment and change of Local Representatives, including appointment timing, inclusion in the drug registration certificate, conditions for Local Representatives, and their registration and change management.
China Drug Regulatory Trends for Local Representatives
With the MAH policy implementation, the Drug Administration Law emphasizes the MAH’s role in full lifecycle management of drugs, ensuring their safety, effectiveness, and quality. By focusing on Local Representatives, the law aims to enhance post-listing management and responsibility implementation, addressing issues like limited regulatory measures due to overseas holders and challenges in communication, information acquisition, investigation, and accountability.
The Drug Administration Law mandates joint and several liability for Local Representatives and overseas MAHs, holding Local Representatives accountable under the law for administrative and criminal responsibilities. This dual responsibility protects patients’ rights and integrates agents into the drug regulatory framework, ensuring MAH responsibilities are fulfilled post-launch. Although the temporary regulations on Local Representatives management are not yet officially implemented, it is evident that administrative requirements for Local Representatives will become increasingly stringent and clear.
China PV Audit: Ensuring Compliance with Pharmacovigilance Regulations
If you are an MAH, ensuring your local representative in China meets regulatory requirements and reduces risks is crucial. A China PV audit can verify compliance, helping navigate China’s pharmacovigilance landscape and maintain product integrity and safety.
Contact Us
If you require a China PV audit on your local rep in China, please contact us at info@accestra.com
Visit www.ChinaPvHub.com a go to resource hub for all things about Pharmacovigilance in China.