[Federal Register Volume 64, Number 149 (Wednesday, August 4, 1999)]
[Notices]
[Pages 42392-42393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19977]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-0017]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Guidance on Validation of Analytical Procedures: Methodology;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final guidance for industry entitled ``Validation of
Analytical Procedures: Methodology.'' This guidance has been adapted
for veterinary use by the International Cooperation on Harmonisation of
Technical Requirements for Registration of Veterinary Medicinal
Products (VICH) from an identically titled guidance adopted by the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) and published in
the Federal Register. The guidance provides recommendations on how to
consider various validation characteristics for each analytical
procedure included as part of registration applications for approval of
veterinary medicinal products submitted to the European Union, Japan,
and the United States.
DATES: Submit written comments at any time.
ADDRESSES: Copies of the final guidance document entitled ``Validation
of Analytical Procedures: Methodology'' may be obtained on the Internet
from the CVM home page at ``http://www.fda.gov/cvm/fda/TOCs/
guideline.html''. Persons without Internet access may submit written
requests for single copies of the final guidance to the Communications
Staff (HFV-12), Center for Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-
addressed adhesive label to assist that office in processing your
requests. Submit written comments on the final guidance document to the
Policy and Regulations Team (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
FOR FURTHER INFORMATION CONTACT:
Regarding this guidance: William G. Marnane, Center for Veterinary
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-6966, e-mail ``[email protected]''.
Regarding VICH: Sharon R. Thompson, Center for Veterinary Medicine
(HFV-3), Food and Drug Administration, 7500 Standish Pl., Rockville, MD
20855, 301-594-1798, e-mail ``[email protected]''.
SUPPLEMENTARY INFORMATION: In recent years, many important initiatives
have been undertaken by regulatory authorities, industry associations,
and individual sponsors to promote the international harmonization of
regulatory requirements. FDA has participated in efforts to enhance
harmonization and has expressed its commitment to seeking
scientifically based harmonized technical procedures for the
development of pharmaceutical products. One of the goals of
harmonization is to identify and reduce the differences in technical
requirements for drug development among regulatory agencies.
FDA has actively participated in the ICH for several years to
develop harmonized technical requirements for the approval of human
pharmaceutical products among the European Union, Japan, and the United
States. The VICH is a parallel initiative for veterinary pharmaceutical
products. The VICH is concerned with developing harmonized technical
requirements for the approval of veterinary pharmaceutical products in
the European Union, Japan, and the United States, and includes input
from both regulatory and industry representatives.
The VICH meetings are held under the auspices of the Office
International des Epizooties (OIE). During the initial phase of the
VICH, an OIE representative chairs the VICH Steering Committee. The
VICH Steering Committee is composed of member representatives from the
European Commission; the European Medicines Evaluation Agency; the
European Federation of Animal Health; the U.S. FDA; the U.S. Department
of Agriculture; the Animal Health Institute; the Japanese Veterinary
Pharmaceutical Association; and the Japanese Ministry of Agriculture,
Forestry, and Fisheries.
Four observers are eligible to participate in the VICH Steering
Committee: One representative from the Government of Australia/New
Zealand, one representative from industry in Australia/New Zealand, one
representative from MERCOSUR (Argentina, Brazil, Uruguay, and
Paraguay), and one representative from Federacion Latino-Americana de
la Industria para la Salud Animal. The VICH Secretariat, which
coordinates the preparation of documentation, is provided by the
Confederation Mondiale de L'Industrie de la Sante Animale (COMISA). A
COMISA representative also participates in the VICH Steering Committee
meetings.
This guidance has been adapted for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH) from an
identically titled guidance adopted by the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) and published in the Federal
Register of May 19, 1997 (62 FR 27464).
In the Federal Register of January 27, 1998 (63 FR 3907), FDA
published this guidance in draft form, giving interested persons until
March 30, 1998, to submit comments. After consideration of comments
received, a final draft guidance was submitted to the VICH Steering
Committee.
At a meeting held on October 20 through 22, 1998, the VICH Steering
Committee endorsed the draft guidance for industry entitled
``Validation of Analytical Procedures: Methodology.'' This guidance
discusses common analytical procedures and provides guidance and
recommendations on how to consider the various validation
characteristics for each analytical procedure included as part of a
registration application for approval of veterinary medicinal products.
It also indicated the various data that should
[[Page 42393]]
be included in registration applications. This guidance will be
implemented in October 1999.
This guidance represents the agency's current thinking on
characteristics for consideration during the validation of the
analytical procedures included as part of applications. It does not
create or confer any rights for or on any person and will not operate
to bind FDA or the public. An alternate approach may be used if it
satisfies the requirements of applicable statutes, regulations, or
both.
As with all of FDA's guidance, the public is encouraged to submit
written comments with new data or other new information pertinent to
this guidance. The comments in the docket will be periodically reviewed
and, where appropriate, the guidance will be amended. The public will
be notified of any such amendments through a notice in the Federal
Register.
Dated: July 28, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-19977 Filed 8-3-99; 8:45 am]
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