China Domestics Responsible Person for Overseas Drug Marketing License Holders administration Interim Regulations have been announced by the National Medical Products Administration (NMPA) on November 13, 2024. This regulation will come into effect on July 1, 2025, introducing stricter post-marketing requirements for imported drugs.
These regulations aim to ensure the safety, efficacy, and quality of overseas-produced medicines throughout their lifecycle by holding both foreign license holders and their designated domestic representatives accountable.
Key Highlights of the Regulation
1) Objective and Scope
The provisions are designed to strengthen the supervision of overseas drug marketing license holders, ensuring they fulfill their obligations for drug quality and safety post-market. The regulations apply to foreign holders of drug registration certificates issued by the NMPA and the domestic entities they designate as responsible parties in China.
2) Definition of Domestic Responsible Person (DRP)
A DRP is a legally registered enterprise in China authorized by a foreign license holder to fulfill marketing authorization obligations. The DRP shares joint liability with the foreign license holder for drug-related activities, including compliance with regulatory standards.
3) Mandatory Requirements for DRPs
To qualify, a DRP must:
o Be an enterprise legal person registered in China.
o Maintain a robust quality management system compatible with drug marketing responsibilities.
o Employ qualified personnel to oversee drug quality management.
o Have appropriate office facilities. Non-compliance with these criteria can result in suspension of drug imports or sales.
Responsibilities of the DRP
The DRP plays a critical role in post-marketing drug oversight, including:
• Ensuring Drug Quality and Safety: Establishing systems for continuous quality assurance and risk control.
• Implementing Traceability Systems: Ensuring all listed drugs are traceable and providing traceability data as required.
• Monitoring Adverse Reactions: Establishing a pharmacovigilance system to monitor and manage safety risks.
• Managing Recalls and Complaints: Handling quality issues and recalls, while reporting to provincial regulatory authorities.
• Annual Reporting: Establishing systems for Drug Annual Report Management System. Submitting yearly updates on production, sales, and risk management activities for imported drugs.
• Registration Management: Establishing and implementing a post marketing change and drug re registration management system, and handling change matters in accordance with regulations.
• Registration and Post-marketing Test: Submit reference standards to the China National Institute for Food and Drug Control in accordance with regulations, actively cooperate with the drug supervision and management department to organize and implement sampling and batch issuance related work.
• Cooperating with Inspections: Assisting regulators with site inspections and investigations into safety or compliance violations.
Procedures for Designating and Reporting DRPs
• Before importing or selling a drug, foreign holders must designate a DRP and report the appointment via the NMPA website (https://zwfw.nmpa.gov.cn)
• Authorization documents, including contact details and a notarized list of responsibilities, must be submitted.
• Changes in DRP details must be reported within 15 working days, and annual reports must include updates on any changes.
Transparency and Public Access
To enhance transparency, the DRP’s name, address, and contact information must be included in the drug’s labeling. This information will also be publicly accessible via the NMPA’s official database.
Supervision and Penalties
Provincial drug regulators will oversee DRPs within their jurisdictions. Non-compliance with the provisions can result in penalties such as warnings, mandatory rectifications, or suspension of sales and imports. Severe violations may lead to legal action under China’s Drug Administration Law and Vaccine Administration Law.
Transition Period
The regulation allows an 8-month transition period for foreign license holders to align with the new requirements. By July 1, 2025, all imported drugs must comply, including updated labeling to reflect DRP information. These interim provisions underline China’s commitment to ensuring the safety and efficacy of imported drugs through enhanced accountability and transparency.
Pharmaceutical companies must act swiftly to appoint qualified DRPs, update processes, and meet the regulatory deadline to avoid disruptions in their China operations.
Further Information
Read the original NMPA announcement on China Domestics Responsible Person for Overseas Drug Marketing License Holders Interim Regulations.
For more information on how these guidelines might impact your development process, contact us to learn about our specialized drug registration and filing services in China.
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