The current China Drug Master File (DMF) filing system introduced by NMPA for Active Pharmaceutical Ingredients (APIs), Excipients and Packaging Materials was implemented since end of 2017, which has significantly reduced the costs and timeline to access the China market compared to the previous pre-approval system.
BaiPharm provides end-to-end China DMF filing services for APIs, pharmaceutical excipients, and packaging materials — covering feasibility assessment, data gap analysis, dossier translation and compilation, CDE submission, and full review-process support through to approval.
Regulatory Context
The current China Drug Master File (DMF) filing system introduced by NMPA for Active Pharmaceutical Ingredients (APIs), Excipients and Packaging Materials was implemented since end of 2017 which has significantly reduced the costs and timeline to access the China market compared to previous pre-approval system.
Product Scope of DMF Filing
China DMF covers three categories:
Drug Substance/Active pharmaceutical ingredient (API)
Pharmaceutical Excipient
Pharmaceutical Packaging Material
DMF Filing Procedure
1Step 1
Conduct an initial assessment of material completeness to determine whether the provided materials are generally complete.
2Step 2
Perform a detailed data gap analysis and provide guidance on the supplementary data required in accordance with China regulatory requirements.
3Step 3
Prepare the DMF dossier in Chinese and submit it to CDE.
4Step 4
CDE conducts a format review of the dossier and provides feedback, if any, within 5 working days.
5Step 5
CDE issues an inactive filing number within 2-4 weeks after completion of the format review.
6Step 6
CDE conducts a technical review. The review queue time may vary depending on the progress of the associated drug product review.
Post-submission Timeline
DMF Public Information
Upon completion of the format review, the basic information of APIs, excipients, and packaging materials will be publicly disclosed on the official website of the China CDE-NMPA (Center for Drug Evaluation). This includes: DMF filing number, product name, company name and address, pack size, announcement date, and approval status.
Products designated as "Inactive" are limited to pharmaceutical research purposes.
Only products designated as "Active" may be used in the commercial manufacture of finished drug products.
DMF Filing Timeline & Cost
For a tailored timeline and cost estimate based on your product type, material readiness, and chosen review pathway, please contact our DMF filing team for a free initial consultation.
Our Services
China DMF Filing Service
API filing and renewal
Pharmaceutical packaging material filing
Pharmaceutical excipient filing
Annual report preparation and submission
Dossier preparation, translation and submission
Post-approval variation application
Binding Registration Service
Mini-pack dossier preparation
Technical review follow-up
China DMF Filing Consulting
Regulatory affairs advisory on DMF filing
Feasibility assessment on DMF filing
Pathway suggestion & risk assessment
Assist in communication with CDE
China DMF Regulatory Compliance Advisory
Dossier compliance assessment and GAP analysis
Production site auditing support
NIFDC sample testing support
Local agent service
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 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.
With extensive experience in DMF filing and post-approval variation management in China, we have successfully provided professional regulatory consulting services for more than 200 DMF filing projects for multinationals and top local pharmaceutical manufacturers.
We develop tailored filing strategies for both independent review pathway (for APIs only) and binding review pathway (for APIs, excipients and packaging materials). Our end-to-end services cover feasibility assessment, data gap analysis, dossier translation, compilation and submission, as well as comprehensive support throughout the review process, including liaison with the CDE, coordination of NIFDC sample testing, arrangement of on-site GMP inspections, and preparation of mini-package documentation for binding review.
Leveraging our in-depth understanding of NMPA regulations and CDE review requirements, we efficiently address deficiency questions and supplementary information requests, mitigate regulatory risks, and facilitate successful approvals. We provide fully compliant, one-stop DMF filing services for APIs, excipients and pharmaceutical packaging materials, complemented by local agent services for overseas applicants.
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