[Federal Register Volume 62, Number 90 (Friday, May 9, 1997)]
[Notices]
[Pages 25634-25635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12157]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96D-0028]
International Conference on Harmonisation; Guideline on Stability
Testing for New Dosage Forms; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a
guideline entitled ``Stability Testing for New Dosage Forms.'' The
guideline was prepared under the auspices of the International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH). The guideline addresses the
generation of stability information for new dosage forms for submission
to FDA by the owner of the original application. The guideline is an
annex to the ICH guideline entitled ``Stability Testing of New Drug
Substances and Products.''
DATES: Effective June 9, 1997. Written comments may be submitted at any
time.
ADDRESSES: Submit written comments on the guideline to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Copies of the guideline
are available from the Drug Information Branch (HFD-210), Center for
Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Regarding the guideline: Guiragos K. Poochikian, Center for Drug
Evaluation and Research (HFD-570), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1050.
Regarding ICH: Janet J. Showalter, Office of Health Affairs (HFY-
20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-0864.
SUPPLEMENTARY INFORMATION: In recent years, many important initiatives
have been undertaken by regulatory authorities and industry
associations to promote international harmonization of regulatory
requirements. FDA has participated in many meetings designed to enhance
harmonization and is committed to seeking scientifically based
harmonized technical procedures for pharmaceutical development. One of
the goals of harmonization is to identify and then reduce differences
in technical requirements for drug development among regulatory
agencies.
ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission, the European Federation of Pharmaceutical Industries
Associations, the Japanese Ministry of Health and Welfare, the Japanese
Pharmaceutical Manufacturers Association, the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA, and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, the Canadian Health Protection Branch, and the
European Free Trade Area.
In the Federal Register of March 6, 1996 (61 FR 9060), FDA
published a draft tripartite guideline entitled ``Stability Testing for
New Dosage Forms.'' The notice gave interested persons an opportunity
to submit comments by June 4, 1996.
After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies at the ICH meeting held on November 5, 1996.
In the Federal Register of September 22, 1994 (59 FR 48754), FDA
published a guideline entitled ``Stability Testing of New Drug
Substances and Products.'' The guideline addresses the generation of
stability information for submission to FDA in new drug applications
for new molecular entities and associated drug products. For
biotechnological/biological products, see ``Quality of
Biotechnological/Biological Products: Stability Testing of
Biotechnological/Biological Products'' (60 FR 43501, August 21, 1995).
This guideline is an annex to that guideline and addresses the
generation of stability information for new dosage forms for submission
to FDA by the owner of the original application, after the original
submission for new drug substances and products.
This guideline represents the agency's current thinking on
stability testing for new dosage forms. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute, regulations, or both.
As with all of FDA's guidelines, the public is encouraged to submit
written comments with new data or other new information pertinent to
this guideline. The comments in the docket will be periodically
reviewed and, where appropriate, the guideline will be amended. The
public will be notified of any such amendments through a notice in the
Federal Register.
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the guideline.
Two copies of any comments are to be submitted, except that individuals
may submit one copy. Comments are to be identified with the docket
number found in brackets in the heading of this document. The guideline
and received comments may be seen in the office above between 9 a.m.
and 4 p.m., Monday through Friday. An electronic version of this
guideline is available on the Internet using the World Wide Web (WWW)
(http://www.fda.gov/cder/guidance.htm).
The text of the guideline follows:
[[Page 25635]]
Stability Testing for New Dosage Forms
1. General
This document is an annex to the ICH Harmonized Tripartite
Guideline on Stability Testing of New Drug Substances and Products
and addresses the recommendations on what should be submitted
regarding stability of new dosage forms by the owner of the original
application, after the original submission for new drug substances
and products.
2. New Dosage Forms
A new dosage form is defined as a drug product which is a
different pharmaceutical product type, but contains the same active
substance as included in the existing drug product approved by the
pertinent regulatory authority.
Such pharmaceutical product types include products of different
administration route (e.g., oral to parenteral), new specific
functionality/delivery systems (e.g., immediate release tablet to
modified release tablet) and different dosage forms of the same
administration route (e.g., capsule to tablet, solution to
suspension).
Stability protocols for new dosage forms should follow the
guidance in the parent stability guideline in principle. However, a
reduced stability database at submission time (e.g., 6 months
accelerated and 6 months long-term data from ongoing studies) may be
acceptable in certain justified cases.
Dated: May 2, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-12157 Filed 5-8-97; 8:45 am]
BILLING CODE 4160-01-F