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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. They:

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these.

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II.3. Applicant means any person who submits an application or abbreviated application or an amendment or supplement to them to obtain FDA approval of a new drug or an antibiotic drug and any other person who owns an approved application (21 CFR 314.3 (b)).

II.4. Drug product means a finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients (21 CFR 314.3 (b)).

Summarize all significant steps in the manufacturing and controls of the drug intermediate or substance. Detailed guidance on what should be included in a Type II DMF for drug substances and intermediates may be found in the following guidelines:

Manufacturing procedures and controls for finished dosage forms should ordinarily be submitted in an IND, NDA, ANDA, or Export Application. If this information cannot be submitted in an IND, NDA, ANDA, or Export Application, it should be submitted in a DMF. When a Type II DMF is submitted for a drug product, the applicant/sponsor should follow the guidance provided in the following guidelines:

Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Typically, a DMF is filed when two or more firms work in partnership on developing or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details.

Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.

The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.

(a) A drug master file is a submission of information to the Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigational new drug application under part 312 or submits an application or an abbreviated application or an amendment or supplement to them under this part, or to permit the holder to authorize other persons to rely on the information to support a submission to FDA without the holder having to disclose the information to the person. FDA ordinarily neither independently reviews drug master files nor approves or disapproves submissions to a drug master file. Instead, the agency customarily reviews the information only in the context of an application under part 312 or this part. A drug master file may contain information of the kind required for any submission to the agency, including information about the following:

(5) FDA-accepted reference information. (A person wishing to submit information and supporting data in a drug master file (DMF) that is not covered by Types II through IV DMF's must first submit a letter of intent to the Drug Master File Staff, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266.) FDA will then contact the person to discuss the proposed submission.

(b) An investigational new drug application or an application, abbreviated application, amendment, or supplement may incorporate by reference all or part of the contents of any drug master file in support of the submission if the holder authorizes the incorporation in writing. Each incorporation by reference is required to describe the incorporated material by name, reference number, volume, and page number of the drug master file.

(c) A drug master file is required to be submitted in two copies. The agency has prepared guidance that provides information about how to prepare a well-organized drug master file. If the drug master file holder adds, changes, or deletes any information in the file, the holder shall notify in writing, each person authorized to reference that information. Any addition, change, or deletion of information in a drug master file (except the list required under paragraph (d) of this section) is required to be submitted in two copies and to describe by name, reference number, volume, and page number the information affected in the drug master file.

(d) The drug master file is required to contain a complete list of each person currently authorized to incorporate by reference any information in the file, identifying by name, reference number, volume, and page number the information that each person is authorized to incorporate. If the holder restricts the authorization to particular drug products, the list is required to include the name of each drug product and the application number, if known, to which the authorization applies.

(e) The public availability of data and information in a drug master file, including the availability of data and information in the file to a person authorized to reference the file, is determined under part 20 and 314.430.

A master file is a confidential document that covers detailed information about facilities, processes and articles used in the manufacturing, processing, packaging, and storing of biologic, drug, and device products. Master files may also cover other types of information including toxicology and shared system Risk Evaluation and Mitigation Strategies (REMS).

Master files are submitted directly to the Food and Drug and Administration (FDA) by a manufacturer and can subsequently be referenced in applicant or sponsor applications to the FDA. This allows the manufacturer to protect its intellectual information from disclosure to an applicant or sponsor while allowing the applicant or sponsor to comply with the regulatory requirements to provide the information as part of an application to the FDA. A Drug Master File (DMF) is not reviewed by the Agency until it is referenced in an applicant or sponsor submission.

Master files may be referenced in applications submitted for both drugs, biologics, and medical devices.

There are four types of master files:

In 2000, the Type I master file was discontinued but the numbering of the other types of master files remain same.

It is noteworthy that for Biologics License Applications (BLAs), the FDA has not generally accepted the inclusion of information about a drug substance, drug substance intermediate, or drug product by reference to a Type II DMF. The Agency expects such information to be submitted directly to the BLA1,2. However, an investigational new drug (IND) application for a biological product may incorporate by reference any information, including drug substance, drug substance intermediate, and drug product information, contained in a master file3.

The terminology used for master file depends on the division of the FDA which will use the master file during a review of an application. Master Files (MFs) (21 CFR 601.51(a)) are reviewed by the Center for Biologics Evaluation and Research (CBER), DMFs (21 CFR 314.420) are reviewed by the Center for Drug Evaluation and Research (CDER), and Device Master Files (MAFs) (21CFR 814.20(c)) are reviewed by the Center for Devices and Radiological Health (CDRH). Throughout this document, the term DMF will be used to refer to master files, unless otherwise noted.

CDER maintains a database containing a publicly available list of DMFs filed with CDER4. The list contains information about the DMF number, activity status (active or inactive), type, holder name and subject (title). The list is updated on a quarterly basis.

This article is written to support and guide manufacturers that are interested in preparing and submitting DMFs to the FDA.

There should be only a single drug substance, drug substance intermediate, type of material used in their preparation, drug product or drug product intermediate in each Type II DMF. For drug substances manufactured using different processes, separate DMFs should be submitted. The manufacturers of drug substance should collect stability data based on the stability protocol and continue to submit data from ongoing studies in a quality/stability amendment15. If a drug substance is sterilized in order to be used in sterile products, the same sterility assurance data should be submitted as for sterile products16 . If a Type V DMF is not cross referenced for the facility and building information including floor plans, it can be submitted in the Type II DMF. If the Chemistry, Manufacturing and Control (CMC) information for material used in the preparation of a drug substance/drug substance intermediate (e.g., cell culture media) is required by the FDA, a Type II DMF may be submitted. e24fc04721