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GUIDANCE DOCUMENT

CVM GFI #85 (VICH GL9) Good Clinical Practice May 2001

Final

CVM GFI #85 (VICH GL9) Good Clinical Practice

Docket Number:
FDA-1999-D-0754
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The objective of this document is to provide guidance on the design and conduct of all clinical studies of veterinary products in the target species.

It is directed at all individuals and organizations involved in the design, conduct, monitoring, recording, auditing, analysis and reporting of clinical studies in target species and is intended to ensure that such studies are conducted and documented in accordance with the principles of Good Clinical Practice (GCP).

Good Clinical Practice is intended to be an international scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting clinical studies evaluating veterinary products.  Compliance with this standard provides public assurance about the integrity of the clinical study data, and that due regard has been given to animal welfare and protection of the personnel involved in the study, the environment and the human and animal food chains.

This guidance has been developed under the principles of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and will provide a unified standard for the European Union (EU), Japan and the United States of America (USA) to facilitate the mutual acceptance of clinical data by the relevant regulatory authorities.  This guidance was developed with consideration of the current practices in the EU, Japan and the USA together with those of Australia and New Zealand.

This guidance should be followed when developing clinical study data that are intended to be submitted to regulatory authorities.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1999-D-0754.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002