Description
This guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions. There are several mechanisms to receive input from the Center for Veterinary Medicine (CVM) prior to submission of the CMC technical section, as well as various approaches to submitting the CMC technical section itself. For review efficiency, CVM prefers that full CMC information be provided in a single technical section submission. However, there may be instances when submission of the individual components of the technical section (drug product, drug substance, and facility sterile process validation (SPV) information for sterile drug products) could reduce the overall time to complete a technical section, and therefore drug approval. This guidance describes the options for soliciting early input from CVM and the process for submission of components of the CMC technical section.
Scope & Applicability
Product Classes
2Specific category of animal drug products
RTRT and CTD sections apply to drug products
Regulatory Context
Attributes
1Reduced regulatory clock for specific resubmissions
Related CFR Sections (2)
- 21CFR514.110§ 514.110 Reasons for refusing to file applications.
(a) The date of receipt of an application for a new animal drug shall be the date on which the application shall be deemed to be filed.Read full regulation →
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead full regulation →
See Also (8)
- CVM GFI #119 How CVM Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug (Status: Final)
- CVM GFI #132 Administrative Applications and the Phased Review Process (Status: Final)
- Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry (Status: Draft)
- CVM GFI #176 (VICH GL39) Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances (Status: Final)
- CVM GFI #216 Chemistry, Manufacturing, and Controls (CMC) Information - Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use (Status: Final)
- CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers (Status: Final)
- CVM GFI #106 The Use of Published Literature in Support of New Animal Drug Approvals (Status: Final)
- CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process (Status: Final)