[Federal Register Volume 66, Number 216 (Wednesday, November 7, 2001)]
[Notices]
[Pages 56332-56333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27958]


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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://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://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or 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]
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