[Federal Register Volume 61, Number 45 (Wednesday, March 6, 1996)]
[Notices]
[Pages 9060-9061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5215]




[[Page 9059]]

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Part VII





Department of Health and Human Services





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Food and Drug Administration



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International Harmonisation Conference; Draft Guideline Availability: 
Stability Testing for New Dosage Forms; Notice

  Federal Register / Vol. 61, No. 45 / Wednesday, March 6, 1996 / 
Notices   

[[Page 9060]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96D-0028]


International Conference on Harmonisation; Draft 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 draft 
guideline entitled ``Stability Testing for New Dosage Forms.'' The 
draft guideline was prepared under the auspices of the International 
Conference on Harmonisation of Technical Requirements for Registration 
of Pharmaceuticals for Human Use (ICH). The draft guideline addresses 
the generation of stability information for new dosage forms for 
submission to FDA by the owner of the original application. The draft 
guideline is an annex to the ICH guideline entitled ``Stability Testing 
of New Drug Substances and Products.''

DATES: Written comments by June 4, 1996.

ADDRESSES: Submit written comments on the draft guideline to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Copies of the draft 
guideline are available from the Division of Communications Management 
(HFD-210), Center for Drug Evaluation and Research, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1012. 
An electronic version of this guideline is also available via Internet 
by connecting to the CDER file transfer protocol (FTP) server 
(CDVS2.CDER.FDA.GOV).

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.
    At a meeting held on November 29, 1995, the ICH Steering Committee 
agreed that a draft guideline entitled ``Stability Testing for New 
Dosage Forms'' should be made available for public comment. The draft 
guideline is the product of the Quality Expert Working Group of the 
ICH. Comments about this draft will be considered by FDA and the 
Quality Expert Working Group. Ultimately, FDA intends to adopt the ICH 
Steering Committee's guideline.
    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 draft 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.
    In the past, guidelines have generally been issued under 
Sec. 10.90(b) (21 CFR 10.90(b)), which provides for the use of 
guidelines to state procedures or standards of general applicability 
that are not legal requirements but are acceptable to FDA. The agency 
is now in the process of revising Sec. 10.90(b). Although this 
guideline does not create or confer any rights for or on any person and 
does not operate to bind FDA in any way, it does represent the agency's 
current thinking on stability testing for new dosage forms.
    Interested persons may, on or before June 4, 1996, submit to the 
Dockets Management Branch (address above) written comments on the draft 
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 
draft guideline and received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    The text of the draft guideline follows:

Stability Testing for New Dosage Forms

1. General

    The ICH harmonized Tripartite Guideline on Stability Testing of 
New Drug Substances and Products was issued on October 27, 1993. 
This document is an annex to the ICH parent stability guideline and 
addresses 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. For 
biotechnological/biological products, see the guideline ``Quality of 
Biotechnological/Biological Products: Stability Testing of 
Biotechnological/Biological 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 

[[Page 9061]]
same administration route (e.g., capsule to tablet, solution to 
suspension).
    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: February 29, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-5215 Filed 3-5-96; 8:45 am]
BILLING CODE 4160-01-F