Overseas Marketing Authorization Holders (MAHs) with approved drugs in China must maintain continuous compliance through post-marketing obligations — including timely annual report submissions, managing post-approval changes, and renewing registration licenses before expiration.
BaiPharm provides end-to-end post-marketing compliance support, covering major change supplementary applications, moderate/minor change notifications, annual report preparation, registration renewal, and Domestic Responsible Person (DRP) solutions for overseas MAHs.
Legal Basis
The following regulations govern post-marketing obligations in China:
Drug Administration Law of the People's Republic of China (2019 Revision);
Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (2026 Amendment);
Provisions of Drug Registration (2020 Revision);
Provisions for Post-approval Changes of Drugs (Interim).
Post-Marketing Obligations
Manage post-approval changes, including major changes (supplementary applications subject to review and approval), moderate changes (change notifications), and minor changes (annual report submissions);
Maintain valid drug registration licenses through timely renewal;
Submit annual reports in accordance with regulatory requirements;
Fulfill the responsibilities and obligations of the MAH.
Our Services
Preparation and submission of dossiers for drug renewal application, communication with the CDE, preparation and submission of supplementary documents until review conclusion;
Feasibility assessment or data gap analysis for the supplementary applications (major changes) to avoid possible deficiencies in application dossier and to minimize the risk of rejection;
Supplementary application dossier review, translation, drafting and submission;
All-the-way consulting service for supplementary application until review conclusion, including communications with CDE reviewers, reply to deficiency letters from CDE, preparation and submission of supplementary documents;
Preparation and submission of dossiers for notification-related changes (moderate changes);
Preparation and submission of dossiers for reporting-related changes (minor changes);
Preparation and submission of annual reports;
Consulting on regulatory obligations and responsibilities, as well as Domestic Responsible Person (DRP) solutions for overseas MAHs, including management system establishment and implementation services.
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 help pharmaceutical companies ensure continuous compliance and smooth market operations, having supported numerous post-marketing projects including annual reports, post-approval variations, and registration renewals. Through our tailored DRP solutions, we ensure that overseas MAHs can effectively fulfill their ongoing regulatory obligations in China.
We provide full-process Domestic Responsible Person (DRP) services and integrated global solutions for Pharmaceutical Intermediates, APIs, Excipients, Packaging Materials, Drug Products, and Medical Devices. Our offerings include Product Registration, Pharmacovigilance (PV), GxP Compliance, Regulatory Intelligence & Consulting, and Toxicological Risk Assessment, ensuring compliant, efficient, and reliable market entry.
Related REACH24H Resources and Services
Explore more BaiPharm pharmaceutical regulatory services:
NDA/BLA/ANDA Registration & Renewal
Clinical Trial Applications (IND/CTA)
Domestic Responsible Person (DRP)
GxP Compliance
Pharmacovigilance (PV)
Toxicological Risk Assessment
Not sure where to start? Our regulatory experts are ready to help.
Email: customer@reach24h.com
