November 14, 2024
The National Medical Products Administration (NMPA) has officially released the Interim Provisions on the Management of Domestic Agents Designated by Overseas Marketing Authorization Holders (MAH) of Drugs, with new regulations effective from July 1, 2025. These measures are set to strengthen the oversight of overseas MAHs by mandating the appointment of a designated domestic agent within China to manage post-market responsibilities. This announcement is significant for overseas pharmaceutical companies aiming to bring their products into the Chinese market.
As a leading regulatory affairs consulting firm, Accestra Consulting offers comprehensive support to help overseas drug manufacturers comply with this new regulatory requirement. Our services ensure seamless coordination with NMPA standards, aiding in designating qualified domestic agents and navigating the application process through the updated NMPA drug business application system.
Key Points of the New NMPA Regulations:
- Effective Date:
- The new regulations will be enforced starting July 1, 2025, allowing overseas MAHs ample time to designate compliant Chinese agents and prepare for the changes.
- Chinese Agent Requirements:
According to the new interim provisions, designated Chinese agents must:- Be a legally established corporate entity in China.
- Possess a robust quality management system suitable for fulfilling MAH obligations.
- Have a dedicated team for drug quality management.
- Maintain an appropriate physical office in China.
- Compliance Responsibilities:
The designated Chinese agent will be responsible for various post-market duties, including:- Ensuring drug quality and risk control, establishing a post-marketing quality assurance systems.
- Implementing a drug traceability system.
- Managing annual reporting requirements and post-marketing variations.
- Establishing pharmacovigilance system and adverse reaction monitoring.
- Handling recalls, random sampling, overseas onsite inspection and more.
- Reporting and Transparency:
Overseas MAHs must submit the Chinese agent’s authorization documentation to the NMPA before initial drug importation, with the Chinese agent’s details also listed in the product’s drug insert. Additionally, the NMPA will maintain public access to designated Chinese agents’ information. - Assignment of the Designated Agents:
For a single drug marketed in China, an overseas MAH must appoint a single designated agent within China, while the same Chinese agent may be appointed by multiple overseas MAHs and for different imported drugs.
How Accestra Consulting Can Assist
Navigating the complexities of Chinese pharmaceutical regulations can be challenging, especially with the recent updates introduced by the NMPA. Accestra Consulting specializes in regulatory affairs for the pharmaceutical industry, providing expert guidance on compliance, documentation, and application processes. Our services include:
- Chinese Agent Management System Compliance Audit and Consultation:: Support for overseas MAHs in conducting compliance audits of designated Chinese agents or providing consultation services for establishing a compliant Chinese agent management system in accordance with NMPA requirements.
- Documentation and Reporting Support:Assisting with documentation preparation and submission, including annual reports, traceability systems, and adverse event monitoring.
- Regulatory Strategy Consultation:Tailored strategies to ensure that your pharmaceutical products meet all regulatory requirements for a successful market entry in China.
- Chinese Agent Appointment and Compliance:Acting as your designated Chinese agent in China, fully compliant with NMPA standards, and equipped to fulfill all required post-market responsibilities.
With Accestra Consulting as your trusted partner, overseas MAHs can focus on market expansion while we manage the regulatory details. Our team of experts ensures that each step aligns with NMPA’s requirements, from initial documentation to ongoing post-market obligations.
Contact Us
To learn more about how we can support your compliance with the new NMPA regulations, contact Accestra Consulting today. With our expertise in regulatory affairs and Chinese market entry, we streamline the process of designating a Chinese agent and ensure that your business is fully compliant with NMPA’s latest requirements.
Reach out to us at email info@accestra.com for more information.
Source:
https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20241114172951120.html
