[Federal Register: November 7, 2001 (Volume 66, Number 216)]
[Notices]
[Page 56332-56333]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no01-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93D-0139]
International Conference on Harmonisation; Guidance on Q1A
Stability Testing of New Drug Substances and Products; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised guidance entitled ``Q1A(R) Stability Testing
of New Drug Substances and Products.'' The revised guidance was
prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The guidance sets forth
recommendations on the information to be submitted in the stability
data package for a new drug substance or drug product for a
registration application within the three regions of the European Union
(EU), Japan, and the United States. The purpose of the revision is to
add information to certain sections and to provide clarification to
other sections of the guidance.
DATES: This guidance is effective November 7, 2001. Submit written or
electronic comments at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information (HFD-240), Center for Drug Evaluation
and Research, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857; or the Office of Communication, Training and
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and
Research (CBER), 1401 Rockville Pike, Rockville, MD 20852-1448, 301-
827-3844, FAX 888-CBERFAX. Send two self-addressed adhesive labels to
assist the office in processing your requests. Requests and comments
should be identified with the docket number found in brackets in the
heading of this document.
Submit written comments on the guidance to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Chi-wan Chen, Center for Drug Evaluation
and Research (HFD-830), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-2001, or Andrew Shrake, Center for
Biologics Evaluation and Research (HFM-345), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-402-4635.
Regarding the 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:
I. Background
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 EU, 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, Labor 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).
[[Page 56333]]
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 accordance with FDA's good guidance practices (GGPs) regulation
(21 CFR 10.115), this document is being called a guidance, rather than
a guideline.
To facilitate the process of making ICH guidances available to the
public, the agency has changed its procedures for publishing ICH
guidances. As of April 2000, FDA no longer include the text of ICH
guidances in the Federal Register. Instead, we publish a notice in the
Federal Register announcing the availability of an ICH guidance. The
ICH guidance is placed in the docket and can be obtained through
regular agency sources (see the ADDRESSES section). Draft ICH guidances
are left in the original ICH format. Final guidances are reformatted to
conform to the GGP style before publication.
In the Federal Register of April 21, 2000 (65 FR 21446), FDA
published a draft revised tripartite guidance entitled ``Q1A(R)
Stability Testing of New Drug Substances and Products.'' The notice
gave interested persons an opportunity to submit comments by June 5,
2000. The draft revised guidance was a revision of an ICH guidance on
the same topic published in the Federal Register of September 22, 1994
(59 FR 48754).
After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies on November 9, 2000.
ICH Q1A provides guidance on the information to be submitted in the
stability data package for a new drug substance or drug product for a
registration application within the three regions: The EU, Japan, and
the United States. The purpose of the ICH Q1A revision is to add
information to certain sections and to provide clarification to other
sections of the guidance. The following sections are the most important
sections that have been revised:
The section on stress testing of the active substance has
been moved from the glossary to the main text.
The text on test procedures has been brought in line with
the ICH Q6A guidance. Relevant cross-references to other ICH guidances
have been introduced.
The text on testing frequency has been amended for
accelerated testing conditions.
Storage conditions have been described in more detail.
Testing at low temperature and testing of aqueous liquids in
semipermeable containers have been specifically addressed.
The postapproval commitment is now clearly described.
The guidance has also been revised to remove several editorial
inconsistencies, including some revision of the glossary.
This guidance represents the agency's current thinking on stability
testing of new drug substances and products. 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 statutes and regulations.
II. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written or electronic comments on the guidance at any
time. Two copies of any comments are to be submitted, except that
individuals can submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. The
guidance 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 document at
eitherhttp://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/publications.htm.
Dated: October 30, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-27958 Filed 11-6-01; 8:45 am]
BILLING CODE 4160-01-S