Tag: Drug Master File

HOW TO FILE A DMF

DMF (Drug Master File) is a confidential & detailed submission to FDA.

There are several steps involved in filing a DMF with the US FDA:

1. Determine the Type of DMF

Identify the type of DMF you need to file (Type II, III, IV, or V).

2. Prepare the DMF Document

  • Cover Letter: Include a cover letter containing the type of DMF, the specific content included, and contact information.
  • Administrative Information: Provide the DMF holder’s and US Agent’s contact details.
  • Technical Content: This varies depending on the type of DMF. It includes manufacturing processes, specifications, testing methods, stability data, and other technical details.
  • References and Appendices: Include all relevant references, supporting documents, and appendices.

3. Format of Document

The DMF must be prepared according to the FDA guidelines on electronic submissions using the eCTD format.

4. Compile the Submission

  • Ensure all sections are complete and properly formatted.
  • Compile the document into eCTD format.

5. Obtain a Pre-Assigned Number

Request a pre-assigned application number for DMF from the FDA.

6. Submit the DMF

Submit the DMF electronically via the FDA’s ESG portal.

7. Pay the Fee

Type II DMF Submission from an API Manufacturer for a generic drug application need to pay FDA fees. There is no FDA fee for other types of DMF submissions.

8. Acknowledge Receipt

Once submitted, FDA will acknowledge receipt of the DMF.

9. Annual Updates and DMF amendments

  • Submit annual updates and amendments as needed.
  • Keep the FDA informed of any changes to the DMF’s content or contact information.

Liberty Management Group Ltd. can help you DMF submissions & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Drug Master Files

A Drug Master File (DMF) is a confidential and detailed document submitted to the US FDA by a drug manufacturer. It contains comprehensive information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMF submission is not required by FDA regulation. DMF is solely submitted at the discretion of the DMF holder. A MDF is not approved or disapproved. Technical contents of a DMF may be reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application. DMF allows FDA to review this information to ensure the quality and safety of the drug products without disclosing proprietary information to the drug product’s sponsor.

The submission of a DMF can be made by:

  1. API manufacturers
  2. Excipient manufacturers:
  3. Container Closure System manufacturers
  4. Drug Product manufacturers

Types of DMF:

  1. Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (discontinued since September 2010).
  2. Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product.
  3. Type III: Packaging Material.
  4. Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation.
  5. Type V: FDA Accepted Reference Information

Non-US DMF applicants are required to appoint a US Agent in their DMF for FDA communication purpose.

Liberty Management Group Ltd. can help you DMF submissions & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Drug Master File

A Drug Master File or (DMF) is a confidential submission to the US FDA that provides detailed information about facilities, processes, or components used in the manufacturing, processing, packaging, and storing of drugs.

The DMF is submitted by a manufacturer, supplier, or developer of an API (active pharmaceutical ingredient), excipient, or packaging material, and it allows them to provide information to the regulatory authority without disclosing the information to their customers or competitors.

A DMF is referenced in a drug application, such as an ANDA or NDA Application, by the applicant who intends to use the information contained in the DMF to support their own application. The regulatory authority can then review the information in the DMF as part of the evaluation of the drug application.

The purpose of a DMF is to provide information to the regulatory authority, without disclosing proprietary information to the public, to support the regulatory review process of a drug product. This allows the regulatory authority to evaluate the quality, safety, and efficacy of the drug product without needing to disclose confidential information to third parties.

DMF submissions are not mandatory and DMF applications are neither approved nor rejected by FDA. DMFs are subject to strict confidentiality requirements and are not publicly available.

DMF holders are required to notify FDA of any changes in the contents of DMF, authorized parties, transfer of ownership etc. An annual report must be submitted every year listing all changes since the previous annual report. Foreign DMF holders are required to appoint a US Agent in their submissions.

Types of Drug Master Files:

  1. Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
  2. Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  3. Type III: Packaging Material
  4. Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  5. Type V: FDA Accepted Reference Information

Liberty Management Group Ltd. can help you with DMF original and annual report submissions & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

What does a US Agent do?

A US FDA Agent acts as a domestic representative for foreign establishments that are engaged in the manufacturing, processing, packaging, or holding of FDA regulated products, such as food, drugs, medical devices &, cosmetics.

The role of the US Agent is primarily to serve as a point of contact between the FDA and the foreign establishment.

Key responsibilities of a US Agent may include:

  1. Assisting FDA to communicate with foreign establishment including responding to inquiries, submitting required documentation, and facilitating inspections.
  2. Serving as a liaison for regulatory compliance matters, including ensuring that the foreign establishment meets FDA regulatory requirements for the products they are dealing in.
  3. Facilitating the submission of required registrations, listings, and other regulatory submissions to the FDA.
  4. Coordinating with the FDA in the event of product recalls, adverse events, or other safety issues related to products manufactured or distributed by the foreign establishment.
  5. Keeping the FDA updated of any changes that are relevant to the foreign establishment’s operations, such as changes in ownership, new manufacturing processes, or product formulations.

The US Agent plays a critical role in helping foreign establishments navigate the regulatory requirements of the FDA and ensuring compliance with US laws and regulations governing the safety and quality of FDA regulated products.

Liberty Management Group Ltd. can be your US Agent and help with registration & other FDA requirements.

Namrata

Regulatory Consultant

support@libertymanagement.ushttp://www.fdahelp.us

Drug Master File (DMF)

A Drug Master File (DMF) is a confidential submission to FDA to provide detailed information about the facilities, processes or articles used to manufacture, process, package or store human drugs.

DMF submissions are not mandatory and DMF applications are neither approved nor rejected by FDA. It is submitted by a drug manufacturer to provide confidential information about the drug’s quality, safety, and efficacy. The information submitted in a DMF is usually referenced only during the IND, NDA, ANDA or export application. A DMF contains technical information about a drug, including its chemical and physical properties, manufacturing processes, and analytical methods.

DMFs are often submitted by drug manufacturers to support the approval of their drug products. DMFs are subject to strict confidentiality requirements and are not publicly available.

DMF holders are required to notify FDA of any changes in the contents of DMF, authorized parties, transfer of ownership etc. An annual report must be submitted every year listing all changes since the previous annual report. Foreign DMF holders are required to appoint a US Agent in their submissions.

Types of Drug Master Files

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel

Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Type III: Packaging Material

Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

Type V: FDA Accepted Reference Information

Liberty Management Group Ltd. can help you with DMF submissions & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us