Regulatory Overview

A Drug Master File (DMF) is a detailed document that records the chemistry, manufacturing, and control (CMC) information of pharmaceutical products. The primary purpose of DMFs is to provide detailed information on drug substances, manufacturing processes, and packaging materials to regulatory agencies like the FDA (USA), PMDA (Japan), EMEA (Europe), and NMPA (China). This ensures the safety, efficacy, and quality of pharmaceuticals.

DMF Classification

In China, the CDE classifies DMFs into two statuses: “A” (Active) and “I” (Inactive). They are further classified into the following types:

  1. Type I：Information on the synthesis, manufacturing, and quality control of drug substances.
  2. Type II： Information related to drug products.
  3. Type III：Information on excipients.
  4. Type IV：Information on packaging materials.
  5. Type V：Miscellaneous information.

Company Obligations and Strategies

Manufacturers of active pharmaceutical ingredients (APIs), excipients, and packaging materials must submit technical information to regulatory bodies in each country. Overseas manufacturers are advised to register through local agents to maintain communication with regulatory authorities.

ClinChoice Services

Data Provision and Gap Analysis
Providing complete data lists based on DMF application conditions of each country, evaluating product data, and identifying gaps.
Preparation and
Submission
Organizing, preparing, and submitting documents according to regulatory requirements in specified formats (e.g., e-CTD). Responding to feedback from regulatory reviews.
Review Tracking
Monitoring the progress of reviews and submitting additional required information.
DMF Maintenance and
Updates
Maintaining DMF numbers and performing necessary annual updates.

ClinChoice Strengths

Expert Team
Multinational team with extensive experience in pharmaceutical regulations, providing registration services for drugs and APIs.
Efficient Service
Dedicated technical and business consultants ensuring quick responses.
Quality Assurance
High-quality service ensured by extensive consulting experience and multilingual support.

Registration Achievements (Up to end of 2023)

China DMF:
22 registrations

USA DMF:
18 registrations

Europe CEP:
8 registrations

Japan JDMF:
2 registrations

Canada DMF:
2 registrations

Korea DMF:
3 registrations