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

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, ``[email protected]'', 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, ``[email protected]''.

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,

``[email protected]''.

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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