[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
_______________________________________________________________________
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
