[Federal Register Volume 63, Number 146 (Thursday, July 30, 1998)]
[Notices]
[Pages 40721-40722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20310]
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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 Registration of Veterinary Medicinal Products (VICH);
Draft Guidance on Stability Testing of New Animal Drug Substances and
Products (#73), Stability Testing for New Dosage Forms of New Animal
Drugs (#74), and Stability Testing: Photostability Testing of New
Animal Drug Substances and Products (#75); Availability; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for comment of three draft guidance for industry documents
entitled ``Stability Testing of New Animal Drug Substances and
Products,'' ``Stability Testing for New Drug Dosage Forms of New Animal
Drugs,''and ``Stability Testing: Photostability Testing of New Animal
Drug Substances and Products.'' These related draft guidance documents
have been adapted for veterinary use by the International Cooperation
on Harmonisation of Technical Requirements for Registration of
Veterinary Medicinal Products (VICH) from guidelines that were adopted
by the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The draft guidance is intended to provide guidance on stability testing
of new drug substances and products and new dosage forms included as
part of registration applications for approval of veterinary medicinal
products submitted to the European Union, Japan, and the United States.
DATES: Written comments should be submitted by August 31, 1998.
Note: FDA will accept comments after the deadline, but to assure
consideration at the next VICH Committee meeting, we must receive
them by August 31, 1998.
ADDRESSES: Submit written requests for single copies of these draft
guidance documents to the Communications Staff (HFV-12), Center for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 to the
Dockets Management Branch (HFA-
[[Page 40722]]
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Comments should be identified with the full title
of the draft guidance document and the docket number found in brackets
in the heading of this document. See the SUPPLEMENTARY INFORMATION
section of this document for electronic access to the draft guidance
documents.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance documents: William G. Marnane, Center for
Veterinary Medicine (HFV-140), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-0678, e-mail
``[email protected]''.
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]''.
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 harmonization of regulatory
requirements. FDA has participated in efforts to enhance harmonization
and has expressed its commitment to seeking scientifically based
harmonized technical requirements 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 in different countries.
FDA has actively participated in the ICH for several years to
develop harmonized technical requirements for the registration of human
pharmaceutical products among the European Union, Japan, and the United
States. The VICH is a parallel initiative for veterinary medicinal
products. The VICH is concerned with developing harmonized technical
requirements for the registration of veterinary medicinal products in
the European Union, Japan, and the United States, and it includes input
from both regulatory and industry representatives.
The VICH meetings are held under the auspices of the Office
International des Epizooties (OIE). 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. Food and Drug Administration, 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 the 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 participates in the VICH Steering Committee
meetings.
At a meeting held on February 26 and 27, l998, the VICH Steering
Committee agreed that the draft guidance documents entitled ``Stability
Testing of New Animal Drug Substances and Products,'' ``Stability
Testing for New Dosage Forms of New Animal Drugs,'' and ``Stability
Testing: Photostability Testing of New Animal Drug Substances and
Products'' should be made available for public comment. These draft
guidance documents were prepared by the VICH Quality Working Group and
are based on ICH Guidelines that have already been adopted by FDA for
human pharmaceuticals.
The draft guidance entitled ``Stability Testing of New Animal Drug
Substances and Products'' addresses the generation of stability
information that should be included in submissions for applications for
registration or approval of new molecular entities and associated drug
products in the European Union, Japan, and the United States. In this
guidance's discussion of ``stress testing'' for both new drug
substances and drug products, the comment states that ``light testing''
should be an integral part of stress testing and will be considered in
a separate annexed VICH document. That separate draft document is
entitled ``Stability Testing: Photostability Testing of New Animal Drug
Substances and Products,'' and sets out a basic testing protocol for
photostability. The third draft guidance entitled ``Stability Testing
for New Dosage Forms of New Animal Drugs'' is also an annex to
``Stability Testing of New Animal Drug Substances and Products.'' It
addresses the generation of stability information for new dosage forms
for submission by the owner of the original application for
registration, after the original application for new drug substances
and products has been submitted. Comments about these draft guidance
documents will be considered by FDA and the VICH Quality Working Group.
Ultimately, FDA intends to adopt the VICH Steering Committee's final
guidance and to publish as future guidance documents.
These draft guidance documents, developed under the VICH process,
have been revised to conform to FDA's Good Guidance Practices (62 FR
8961, February 27, l997) . For example, the documents have been
designated ``guidance'' rather than ``guideline.'' Since guidance
documents are not binding, mandatory words such as ``must,'' ``shall,''
and ``will'' in the original VICH documents have been substituted with
``should.''
These draft guidance documents represent current FDA thinking on
stability testing of new animal drug substances and products and new
dosage forms of new animal drugs. The documents do not create or confer
any rights for or on any person and will not operate to bind FDA or the
public. Alternate approaches may be used if they satisfy the
requirements of applicable statutes, regulations, or both.
II. Comments
Interested persons may, on or before August 31, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
the guidance documents. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments should be
identified with the docket number found in brackets in the heading of
this document. A copy of the guidance documents and received comments
are available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the guidance
documents using the World Wide Web (WWW). For WWW access, connect to
CVM at ``http://www.fda.gov/cvm''.
Dated: July 23, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20310 Filed 7-29-98; 8:45 am]
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