DMF Filling for Active Pharmaceutical Ingredients, Excipients and Packaging Materials

DMF: Drug Master File; API: Active Pharmaceutical Ingredient

Legal Basis

Drug Administration Law of the People’s Republic of China (2019 Revision);
Provisions for Drug Registration;
Announcement No. 146 of CFDA, 2017: Announcement of Adjustment on the Review and Approval Procedure of APIs, Pharmaceutical Excipients and Packaging Materials;
Announcement No. 56 of NMPA, 2019, Announcement of Improvement on the Separated Filing and Linked Review System of Drug Products and the Supervision.

Product Scope

APIs, pharmaceutical excipients, and packaging materials are developed, produced, imported and used within the territory of the People’s Republic of China.

Applicant Qualification

Chinese manufacturers of APIs, pharmaceutical excipients and packaging materials. Overseas manufacturers or holders of APIs, pharmaceutical excipients and packaging materials. For overseas applicants, a Chinese business entity must be appointed as a local agency.

Filing Type and Procedure

APIs filing, change management and annual report;
Pharmaceutical excipients filing, change management and annual report;
Packaging materials filing, change management and annual report.

Post-Marketing Obligation

Change management, including major, medium, and minor-level changes and basic information change.
Annual report

Our Services

Authorization to act as local agent for product filing;
Support for application materials checklist and data gap analysis for feasibility assessment;
Customized risk evaluation and optimized registration strategy analysis to avoid possible deficiencies in the application dossier and to minimize the risk of rejection;
Document translation and dossier preparation;
For high-risk products, assistance in sample testing and NMPA on-site inspection –on-site pre-audit or mock inspection can be arranged;
All-the-way consulting services for DMF filing, including communications with CDE reviewers, reply to deficiency letters from CDE, preparing and submitting supplementary applications;
Extended service coverage after market approval, including preparation and submission of annual reports, and applications for change management.

Why Choose BaiPharm

Our experts have achieved a thorough professional understanding of pharmaceutical regulations and extensive experience to provide solutions across all critical stages in the drug life cycle. We’re committed to providing clients with professional and customizable pharmaceutical regulatory compliance services, including market entry consultation and registration of prescription drugs, OTCs, APIs, excipients and packaging materials. Our constant driver is to ensure high-level professional and efficient solutions for outstanding pharmaceutical enterprises across the globe.