Effective July 1, 2025, all overseas Marketing Authorization Holders (MAHs) must appoint a qualified legal entity in mainland China as their Domestic Responsible Person (DRP) under NMPA's Interim Provisions. The DRP shares joint and several liability with the MAH for drug quality, safety, and compensation throughout the product lifecycle.
BaiPharm offers two flexible DRP service models — either serving as your designated DRP or assisting your own Chinese entity to become a compliant DRP — with full support for quality system establishment, regulatory filing, pharmacovigilance, annual reporting, and emergency management.
Regulatory Context
In November 2024, the NMPA released the Interim Provisions on the Management of Designated Domestic Responsible Person (DRP). These provisions mandate that all overseas Marketing Authorization Holders (MAHs) must appoint a qualified legal entity in mainland China to act as their local representative.
What is "DRP of Overseas MAH"?
Effective July 1, 2025, the new framework introduces several critical mandates for overseas pharmaceutical companies:
An overseas MAH must designate a qualified legal entity registered in China as the domestic responsible person.
The overseas MAH bears primary responsibility for the entire lifecycle of the drug, while the DRP shares joint and several liability with the MAH.
The overseas MAH shall report to the provincial drug regulatory authority where the DRP is located and submit the authorization documents.
The DRP is subject to supervision and inspection by the respective provincial drug regulatory authority.
The information of the DRP shall be listed in the package insert. For the first import filing after the provisions take effect, the port drug regulatory authority will verify the DRP information in the package insert.
Each drug product shall be designated a sole DRP in China.
Main Scope of Work for the DRP
Joint Liability: DRP is designated by the overseas MAH to fulfill the obligations of the MAH within the territory of China. The DRP shall bear joint liability with the MAH.
Full Compliance System Establishment: Assist the overseas MAH in establishing a quality system compliant with Chinese laws and regulations. The system remains under the ownership of the MAH. Compliance strategies can be customized based on regulatory differences across provinces.
Qualification Review: Audit the existing quality system of the overseas MAH to identify gaps with the new requirements (e.g., personnel arrangements, documentation deficiencies).
Designation of DRP: Assist in preparing the Joint Commitment Letter of Obligations and the Authorized Responsibility List.
System Filing: Submit relevant documents for the designation of the DRP via the National Drug Business Application System, with information simultaneously transmitted to the regulatory platforms of 31 provinces.
Package Insert Update: Revise the package insert to include the information of DRP.
Annual Report: Submit the annual report by April 30 each year.
Designation Process of the DRP
The full designation process involves preparation of authorization documents, quality system audit, submission via the National Drug Business Application System, simultaneous transmission to 31 provincial regulatory platforms, package insert revision, and ongoing annual reporting obligations.
Frequently Asked Questions
Our Services
To address the diverse needs of overseas MAHs under the new regulations, BaiPharm offers two distinct service models:
Model 1: BaiPharm as the DRP
Regulatory Responsibility:
Assume legal responsibilities in accordance with the Drug Administration Law as the designated DRP;
Act as the official liaison with the NMPA, review centers, and testing institutions.
Establishment of a Local Quality Management System:
Establish a locally compliant quality system in accordance with regulations and GxP requirements;
Implement the drug quality assurance system, change control, supply chain management, and other related activities.
Drug Safety and Emergency Management:
Assist the client in establishing and operating a pharmacovigilance system in compliance with Chinese GVP;
Handle quality complaints, defective product recalls, and emergency incident responses;
Provide a 24-hour emergency contact to fulfill regulatory requirements.
Annual Report: Assist in the submission of the annual report.
Model 2: Assisted DRP Compliance
Quality System Establishment for the DRP:
Guide enterprises in understanding and fulfilling the legal obligations of a DRP;
Assist in establishing a system framework for document management, quality responsibilities, and risk control;
Develop Standard Operating Procedures (SOPs) and quality responsibility assignment documents.
Specialized Training and Capacity Building:
Provide compliance training on regulations, quality, and PV for management and relevant personnel;
Offer guidance on communication with overseas MAHs, audit implementation, and data transfer mechanisms;
Organize mock on-site inspections to support enterprises in responding to regulatory audits.
Filing & Communication Support:
Assist in drafting responsibility agreements between overseas MAH and the DRP;
Review filing documents to ensure compliance with regulatory requirements.
Why Choose BaiPharm?
BaiPharm, a specialized subsidiary of REACH24H Consulting Group, is dedicated to pharmaceutical regulatory compliance. With offices in the U.S., EU, Japan, and South Korea, our expert team — including regulatory specialists, GxP auditors, consultants, certified toxicologists, and former inspectors — has supported over 600 pharmaceutical firms from 26 countries.
We possess in-depth insight into NMPA DRP requirements and have developed a mature, practice-oriented MAH/DRP service system through long-term involvement with multiple authorized products. This hands-on experience has enabled us to gain a strong understanding of real-world operational challenges in China and establish effective communication channels with regulatory authorities, allowing for timely alignment and issue resolution.
Our professional team consists of regulatory specialists and GxP auditors with extensive practical experience, specializing in establishing GxP-compliant quality and pharmacovigilance systems. We are well-versed in provincial regulatory differences as well as joint liability requirements, and are able to support overseas MAHs in effectively fulfilling their regulatory responsibilities and ensuring sustainable, full lifecycle compliance in China.
Related REACH24H Resources and Services
Explore more BaiPharm pharmaceutical regulatory services:
NDA/BLA/ANDA Registration & Renewal
Clinical Trial Applications (IND/CTA)
Post-Marketing Compliance
GxP Compliance
Pharmacovigilance (PV)
Local Agency Support
Not sure where to start? Our regulatory experts are ready to help.
Email: customer@reach24h.com
