[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