The document summarizes key aspects of a Drug Master File (DMF), including: 1. A DMF provides confidential manufacturing and quality information to regulatory authorities that multiple applicants can reference. This ensures confidentiality for manufacturers while allowing regulatory review of their processes and materials. 2. The main parts of a DMF are the restricted part containing confidential manufacturing details, and the applicant's part with non-confidential characterization and quality control information. 3. DMF requirements and procedures vary by country or region, but generally serve to provide standardized submission of confidential manufacturing information to support drug approvals and applications.

1. SUBJECT: RA (Regulatory Affairs)
Academic Year: 2023-24
ASHOKRAO MANE COLLEGE OF PHARMACY, PETH VADGAON
TITLE OF SEMINAR: DMF (Drug Master File)
Presented by:
Miss. Manjusha P. Bandi
M. Pharm First Year
Department of Pharmaceutics
Guided by:
Dr. Sachin S. Mali
Professor and Head,
Department of Pharmaceutics
13/ 12/ 2023

2. Content:
• Definition
• Benefits of DMF services
• Types of DMF
• Parts of DMF
• Format of DMF
• DMF in different countries

3. Drug Master File
• Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about
facilities, processes or articles used in the manufacturing, processing, Packaging and storing of human drug
products.
• Drug master files are provided for in 21 CFR 314.420
• Drug Master File (MDF) is referred to as the US-Drug Master file (US-DMF) and European Drug Master File
(EDMF) or Active Substance Master File (ASMF) in the United States and Europe, respectively.
• DMFs usually covers the CMC of a drug product.

4. Benefits of DMF
1. Ensures confidentiality of proprietary
2. Gives the applicant an edge over its competitors
3. Several applicants can refer to the information.
4. Adds value to the product and company on the whole.
5. Considered more reliable in terms of quality and regulatory stand by manufacturing companies.
6. Builds confidence within the customers.
7. Improves sales anywhere in the world.
8. Penetrates high entry barrier USA market.

5. Types of DMF

6. Parts of DMF
1. Restricted part
2. Applicant’s part
Restricted part (Closed part):
1. Manufacturer(s) site of manufacturing.
2. Manufacturer.
3. Authority.
4. A detailed description of the manufacturing process and process controls.
5. Control of materials (starting material of the API, reagents, solvents, other materials used).
6. Control of critical steps and intermediates.
7 . Process validation and/or evaluation.
8. Manufacturing process development.

7. Applicant's part (Open part):
• Information regarded as to be non-confidential and to be given to the applicant. This information is also
given to the authority as part of DMF services.
• These parts include:
1. General information.
2. Characterization.
3. Control of API.
4. Reference standards or materials.
5. Container closure system.
6. Stability

9. DMF Format
• DMFs may be submitted following the format recommended in the "Guidance for Industry M4Q: the CTD -
Quality".
• The Common Technical Document is a set of specifications for an application dossier for the registration of
medicines and designed to be used across Europe, Japan, and the USA.
• It was developed by the EMA (Europe), the U.S. FDA tote (USA), and the MHLW (Japan).
• A 6-digit assigned number is used,
• for example, 2345 must be submitted where a sequence number for the first submission in electronic
format.

10. DMF in different countries
1. DMF in India
• There are no guidelines for drug master documents issued by the Central Drug Standards Organization.
• The DMF format is commonly used in the United States to deliver confidential data about drugs and
pharmaceuticals to regulatory authorities in India.
• A DMF can be sent for bulk or prescription drugs.

11. 2. DMF in USA:
• DMF in the USA is a set of documents submitted to the U.S. FDA by a pharmaceutical manufacture.
• The DMF may also provide information which may be confidential for the manufacturer may be required to
the regulatory authority for a complete understanding of their product, facility, and the processes, systems,
types of equipment and article used.
• Types of DMF in USA:
In USFDA the DMF is classified into the following 5 types:
( a) Type I: This DMF is for manufacturing facility or site, technical personnel working for the company, and
operating procedures. Presently, this type of DMF is no longer in use as per Federal Register, January 12, 2000:
65(8), effective on July 10 2000.
b) Type II: This DMF contains a drug molecule, its intermediates, and the starting materials used in the
manufacturing of the drug product as well as the parent drug molecule.

12. (c) Type III: This DMF is for the materials used for the packaging of a drug product.
(d) Type IV: This DMF contains information on colorants additives, excipients, and flavour essences or
substances in drug product manufacturing.
(e) Type V: It contains the information reference which is accepted by the USFDA which cannot be submitted
through Type II to Type IV DMF, FDA generally discourages the use of Type V.

13. 3. DMF in EU:
• The Active Substance Manufacture File (ASMF) procedure, formerly known as the European Substance
Master File (ESMF) procedure is used when ASM is not the applicant for a product marketing
authorization.
• The main objective of the ASMF procedure is to protect the manufacturer of the active substance, allowing
the applicant Marketing Authorization Holder (MAH) to take full responsibility for the medicinal product
and the quality control of the active substance.
There are following four procedures for approvals to market a new product in Europe:
1. Centralized procedure.
2. Decentralized procedure.
3. Mutual recognition procedure.
4. National authorization procedure.
The ASMF procedure can be used for the following active substance, including herbal
1. New active substances.
2. Existing active substances not included in the European Pharmacopoeia (E.P.) or the Pharmacopoeia of
the EU member state.
3. Pharmacopoeial active substances not included in the E.P. or the Pharmacopoeia of the EU member
state.

14. 4. DMF in Japan:
• The DMF system in Japan allows the manufacturers of APIs to submit the detailed information (manufacturing
methods, data, etc.) of APIs to the Review Authority, the PMDA,
• The registered information such as manufacturing methods, data, etc. is considered the necessary information
for an approval review of the pharmaceutical products in which APIs is used.
• DMF is reviewed at the time of the approval review for the pharmaceutical products quoting DMF.
• At the time of DMF registration, PMDA checks whether it is written in the correct format, for example,
minimum required items are included in the application and data is attached as CTD M3.
• In Japan, the DMF is called "Master File" or "MF".

15. • Items which can be registered in MF are as follows:
1. Drug substance and intermediate (for medical use).
2. Pharmaceutical product material (with special doses form).
3. New excipients and pre-mix excipients with a different composition ratio from the existing one.
4. Materials for medical devices.
5. Contains packaging material.

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