Description
A Type VII Veterinary Master File (VMF) is a file that can receive submissions to FDA’s Center for Veterinary Medicine (CVM) that may contain confidential data and information related to unique regulatory considerations such as research and development of animal cells, tissues, and cell- and tissue-based products (ACTPs), intentional genomic alterations (IGAs) in animals, gene therapy, or a risk review for an ACTP or IGA in an animal, where the information submitted is generally not intended to support product approval.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
7ACTPs are novel products subject to Type VII VMF use
Products that modify or manipulate the expression of a gene; Products involving genetic modification; A research scientist in a university laboratory has developed a gene therapy.
IGAs in animals are novel products subject to Type VII VMF use
Animal Cell- and Tissue-based Products
Intentional Genomic Alterations in animals
A company is in the early stages of developing a cell-based product for use in dogs.
A company is developing an ACTP that is minimally manipulated.
Stakeholders
4Includes sponsors, researchers, or individuals interacting with CVM
Entity to which obligations may be transferred
Personnel responsible for conducting investigations
you are considered an 'animal drug sponsor' if you submit an investigational submission.
Regulatory Context
Regulatory Activities
2Determination of whether FDA would exercise enforcement discretion; CVM review of data to determine enforcement discretion
Binding product development discussions with CVM; The company should open an investigational file and request a presubmission conference.
Document Types
4A file for submissions containing confidential data related to ACTPs, IGAs, or gene therapy; A master file for research and development and risk reviews; The Type VII VMF should be updated periodically.
Established when pursuing approval of a defined product; An investigational file is the file type to which a developer submits investigational data.
Required documentation for studies in client-owned animals
Periodic reports for all Type VII VMFs should contain information including updates to the product description.
Attributes
2Protection of data whose disclosure could lead to patient harm
Financial requirements for sponsors
Technical Details
Substances
2Component of gene therapy products
A statement that edible products from food-producing species treated with or containing the product, have not entered the food or feed supply.
Processes
1implied manufacturing process under QS regulation
Clinical Concepts
2Safety findings including deaths and post-mortem examinations
Adverse events resulting in death, hospitalization, or significant disability.
Identified Hazards
Hazards
1Potential risk associated with viral vectors
Related CFR Sections (2)
- 21CFR511.1§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act.
(a) New animal drugs for tests in vitro and in laboratory research animals.Read full regulation →
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
See Also (8)
- Preparation of Investigational New Drug Products (Human and Animal): Guidance for Industry (Status: Final)
- Submitting Debarment Certification Statements (Status: Draft)
- CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals (Status: Final)
- Clinical Investigator Administrative Actions - Disqualification: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors (Status: Final)
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species (Status: Final)
- CVM GFI #251 - Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease (Status: Draft)
- CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process (Status: Final)
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)