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Policy Letter
JUL 26 1995 Dear Sir or Madam: This Policy Letter announces the Center for Veterinary Medicine's informal guidance document entitled "MASTER FILES, Guidance for Industry for the Preparation and Submission of Veterinary Master Files". The Center is issuing this Policy Letter at this time so that guidance will be available to the veterinary industry for the preparation and submission of master files to the Center for Veterinary Medicine. A master file (MF) is a voluntary 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 veterinary drugs. We generally refer to master files on file with the Center for Veterinary Medicine as veterinary master files (VMF's). Whereas, those on file with the Center for Drug Evaluation and Research (CDER) are referred to as drug master files (DMF's). There are no real differences between DMF's and VMF's other than their filing location. The differences in designation are used only for document and filing purposes to avoid confusion in possible numbering systems between the Centers. The information contained in a VMF or DMF may be used to support an investigational new animal drug application, a new animal drug application, an abbreviated new animal drug application, another VMF or DMF, an export application, or amendments or supplements to any of these. A master file is NOT a substitute for an INADA, NADA, ANADA, or Export Application. The master file is used to provide support information and data for an NADA, ANADA, INADA, Export Application, or other master files. It is not approved or disapproved. Rather, the submission is found acceptable or deficient in support of an INADA, NADA, ANADA, Export Application, or other master file. The submission of a master file is not required by law or FDA regulation. Master files are generally created to allow a party other than the holder of the master file to reference material without disclosing to that party the contents of the file. When an applicant references its own material, the applicant should reference the information contained in its own INADA, NADA, or ANADA directly rather than establishing a master file. A master file is submitted solely at the discretion of the holder. All information submitted in a master file is considered confidential, and is reviewed only when the master file holder provides appropriate authorization permitting the FDA to refer to it on behalf of an applicant or sponsor. The Center for Drug Evaluation and Research (CDER) has defined five distinct categories of master file submissions that it will accept and maintain, and has designated these as Type I through Type V drug master files (DMF's), 21 CFR 314.420 (a)(5). The Center for Veterinary Medicine provided for the same five distinct categories of VMFs by referral to a guideline in Section 514.420 (c) of the New Animal Drugs; Proposed Rule ("NADA Rewrite") published in the FEDERAL REGISTER on December 17, 1991. However, the NADA Rewrite has not been published as a Final Rule and the referenced guideline was not issued by the Center for Veterinary Medicine. Consequently, master files on file with the Center for Veterinary Medicine have not officially been designated as Type I through Type V Veterinary Master Files. Rather, these submissions have been accepted and maintained under the general category of Master Files. The recently published proposed rule (60 FR 34486, July 3, 1995) amends the human drug regulations (21 CFR 314.420) and eliminates Type I drug master files for CDER. Prior to eliminating Type I master files the FDA evaluated the usefulness of these submission. The agency determined that its inspectors were not using Type I DMF's to plan inspections and that they could be eliminated without adversely affecting inspections of manufacturing facilities. FDA also determined that its review divisions do not rely on Type I DMF's. Although Type I DMF's are often incorporated by reference, the information that the agency requested to be submitted under Type I DMF's is not required for chemistry, manufacturing, and controls (CMC) review. Additionally, the basic information (e.g. name and location of facilities used in the manufacture of the drug substance or product) is on file as part of the application. Therefore, Type I DMF's could be eliminated without adversely affecting the CMC review. The Center for Veterinary Medicine concurs with these decisions. This information is already evaluated on site by FDA field activities, and a master file containing Type I information is of very limited value to either our review staff or the FDA field investigator. Accordingly, this Policy Letter announces the Center for Veterinary Medicine's informal guidance document entitled "MASTER FILES, Guidance for Industry for the Preparation and Submission of Veterinary Master Files". This guidance document recognizes five distinct types of Veterinary Master Files (Type I - V), as well as, public master files and eliminates Type I VMF's. The Center will no longer accept new Type I VMF's, or correspondence updating existing Type I VMF's. The information in Type I VMF's currently on file could no longer be incorporated by reference into new applications, amendments, or supplements, and the Type I VMF's would be transferred to the Federal Records Center, Suitland, MD. Further comment defining the content of Type I - V Veterinary Master Files and the mechanism by which Type I master files will be eliminated or recategorized as Type II - V veterinary master files are provided in the attached informal guidance document entitled "MASTER FILES, Guidance for Industry for the Preparation and Submission of Veterinary Master Files". Written comments and questions regarding this document are solicited and welcome. These may be addressed to: William G. Marnane Additionally, the attached guidance document announces that a Type II -V Veterinary Master File will only be reviewed in conjunction with an application (INADA, NADA, ANADA, Export Application, or amendments and supplements to these applications). Previously, the Center routinely reviewed submissions (original and amendments to VMF's) that were not necessarily linked to an application. In some instances, these master files were never referenced in support of a pending application. The Center has concluded that the routine review and evaluation of Veterinary Master Files not specifically referenced in applications may be a waste of resources. Therefore, the routine evaluation of updates and amendments to Veterinary Master Files will be discontinued. However, this only serves to emphasize that the affected applicants must be notified of significant changes in a Veterinary Master File that require the submission of an amendment or supplemental application. At that time, the Center (with appropriate authorization) will refer to the Veterinary Master File and evaluate the change in process, etc., and the impact of these changes on the application. This Policy Letter is expected to: 1) Remove an unnecessary burden on the veterinary industry (e.g., maintenance of Type I Master Files) that provide no added value to our review process or that of FDA field staff, 2) Eliminate the expenditure of review effort currently being wasted on the evaluation of Veterinary Master Files containing Type I information, and the expenditure of review effort on master files that are not specifically referenced in support of a pending application, 3) Reduce the number of filings maintained in our document control unit, and 4) provide for similar designation and processing of master files in both the Center for Veterinary Medicine and the Center for Drug Evaluation and Research. As the Center for Veterinary Medicine continues to develop policies and procedures for veterinary drug products, we will continue to keep the public informed through written communications and through meetings with professional societies and associations. We welcome comment from all interested parties. Sincerely yours,
Stephen F. Sundlof, D.V.M., Ph.D.
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