[Federal Register Volume 64, Number 196 (Tuesday, October 12, 1999)]
[Notices]
[Pages 55293-55294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26501]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0566]
International Cooperation on Harmonisation of Technical
Requirements for Approval of Veterinary Medicinal Products (VICH);
Final Guidances entitled ``Stability Testing of New Veterinary Drug
Substances and Medicinal Products'' (VICH GL3); ``Stability Testing of
New Veterinary Dosage Forms'' (VICH GL4); ``Stability Testing:
Photostability Testing of New Veterinary Drug Substances and Medicinal
Products'' (VICH GL5); 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 three final guidances for industry entitled ``Stability
Testing of New Veterinary Drug Substances and Medicinal Products''
(VICH GL3), ``Stability Testing of New Veterinary Dosage Forms'' (VICH
GL4), and ``Stability Testing: Photostability Testing of New Veterinary
Drug Substances and Medicinal Products'' (VICH GL5). These guidances
have been adapted for veterinary use by the International Cooperation
on Harmonisation of Technical Requirements for Approval of Veterinary
Medicinal Products (VICH) from guidances regarding pharmaceuticals for
human use, which were adopted by the International Conference on
Harmonisation of Technical Requirements for Approval of Pharmaceuticals
for Human Use (ICH). These VICH documents provide guidance on stability
testing of new animal drugs and new dosage forms of new animal drugs
included as part of new animal drug applications (referred to as
registration applications in the guidances) submitted to the European
Union, Japan, and the United States.
DATES: You may submit written comments at anytime.
ADDRESSES: Copies of the final guidance documents entitled ``Stability
Testing of New Veterinary Drug Substances and Medicinal Products''
(VICH GL3), ``Stability Testing of New Veterinary Dosage Forms'' (VICH
GL4), and ``Stability Testing: Photostability Testing of New Veterinary
Drug Substances and Medicinal Products'' (VICH GL5) may be obtained on
the Internet from the CVM home page at http://www.fda.gov/cvm/fda/
mappgs/vich.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.
You may submit written comments any time on the final guidance
documents 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 VICH: Sharon Thompson, Center for Veterinary Medicine
(HFV-3), Food and Drug Administration, 7500 Standish Pl., Rockville, MD
20855, 301-594-1798, E-mail, sthompso@cvm.fda.gov'', or
Robert C. Livingston, Center for Veterinary Medicine (HFV-1), Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-
594-5903, E-mail, rlivings@cvm.fda.gov''.
Regarding the guidance documents: William G. Marnane, Center for
Veterinary Medicine (HFV-140), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6966. E-mail,
wmarnane@cvm.fda.gov''.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken
by regulatory authorities, industry associations, and individual
sponsors to promote the international
[[Page 55294]]
harmonization of regulatory requirements. FDA has participated in
efforts to enhance harmonization and has expressed its commitment to
seek 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 and biological 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, European Medicines Evaluation Agency;
European Federation of Animal Health; Committee on Veterinary Medicinal
Products; the U.S. FDA; the U.S. Department of Agriculture; the Animal
Health Institute; the Japanese Veterinary Pharmaceutical Association;
the Japanese Association of Veterinary Biologics; and the Japanese
Ministry of Agriculture, Forestry and Fisheries.
Two observers are eligible to participate in the VICH Steering
Committee: one representative from the government of Australia/New
Zealand, and one representative from the industry in Australia/New
Zealand. 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.
II. Guidance on Stability Testing
These three guidances are entitled ``Stability Testing of New
Veterinary Drug Substances and Medicinal Products'' (VICH GL3),
``Stability Testing of New Veterinary Dosage Forms'' (VICH GL4), and
``Stability Testing: Photostability Testing of New Veterinary Drug
Substances and Medicinal Products'' (VICH GL5). They have been adapted
for veterinary use by the VICH from guidances regarding pharmaceuticals
for human use which were adopted by the ICH and published in the
Federal Register of September 22, 1994 (59 FR 48753), May 9, 1997 (62
FR 25634), and May 16, 1997 (62 FR 27115).
In the Federal Register of July 30, 1998 (63 FR 40721), FDA
published these VICH guidances in draft form, giving interested persons
until August 31, 1998, to submit comments. After consideration of
comments received, final draft guidances were submitted to the VICH
steering committee. At a meeting held on May 20, 1999, the VICH
Steering Committee endorsed the three final draft guidances for
industry, VICH GL3, VICH GL4, and VICH GL5.
VICH GL3 addresses the generation of stability information that
should be included in submissions for new animal drug applications in
the European Union, Japan, and the United States. VICH GL4 is an annex
to VICH GL3 and supplements that document by providing specific
guidance on what should be submitted regarding stability of new dosage
forms by the new animal drug applicant, after the original submission
of stability information made in a new animal drug application. VICH
GL5 is also an annex to VICH GL3 and supplements that document by
providing guidance on basic protocol for photostability testing for new
animal drugs. These guidances will be implemented in May of 2000.
These guidances represent the FDA's current thinking on stability
testing of new animal drugs and new dosage forms of new animal drugs.
They do not create or confer any rights for or on any person and does
not operate to bind FDA or the public. You may use alternative methods
as long as they satisfy the requirements of applicable statute and
regulation.
As with all of FDA's guidances, the public is encouraged to submit
written comments with new data or other new information pertinent to
these guidances. The comments in the docket will be periodically
reviewed, and, where appropriate, the guidances will be amended. The
public will be notified of any such amendments through a notice in the
Federal Register.
Dated: September 30, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-26501 Filed 10-8-99; 8:45 am]
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