[Federal Register Volume 67, Number 250 (Monday, December 30, 2002)]
[Notices]
[Pages 79639-79640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32852]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0509]


International Conference on Harmonisation; Draft Guidance on the 
M4 Common Technical Document--Quality: Questions and Answers/Location 
Issues; 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availability of a draft guidance entitled ``Common Technical Document--
Quality: Questions and Answers/Location Issues.'' The draft guidance 
was prepared under the auspices of the International Conference on 
Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH). In the Federal Register of October 
16, 2001 (66 FR 52634), FDA announced the availability of an ICH 
guidance entitled ``M4 Organization of the Common Technical Document 
for the Registration of Pharmaceuticals for Human Use'' (M4 CTD). This 
draft guidance provides further clarification for preparing the quality 
components of an application file in the CTD format (M4Q: The CTD-
Quality). The draft guidance addresses: (1) The relationship between 
linked sections for certain parameters (such as polymorphism and 
particle size), and (2) location issues (by indicating the section in 
which to place requested information). The draft guidance is intended 
to ease the preparation of paper and electronic submissions, facilitate 
regulatory reviews, and simplify the exchange of regulatory information 
among regulatory authorities.

DATES: Submit written or electronic comments on the draft guidance by 
February 28, 2003.

ADDRESSES: Submit written comments on the draft guidance to the Dockets 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. Submit written requests for 
single copies of the draft guidance to the Division of Drug Information 
(HFD-240), Center for Drug Evaluation and Research, Food and Drug

[[Page 79640]]

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), Food and Drug 
Administration, 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. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Charles P. Hoiberg, Center for Drug 
Evaluation and Research (HFD-800), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5918; or Christopher C. 
Joneckis, Center for Biologics Evaluation and Research (HFM-20), Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-
827-0833.
    Regarding the ICH: Janet J. Showalter, Office of International 
Programs (HFG-1), 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 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, Labour, 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, Health Canada's Health Products and Food 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 procedure for publishing ICH 
guidances. As of April 2000, we 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 will be placed in the docket and can be obtained through 
regular agency sources (see ADDRESSES). Draft guidances are left in the 
original ICH format. The final guidance is reformatted to conform to 
the GGP style before publication.
    In October 2001, FDA made available the ICH guidance M4 CTD, which 
describes a harmonized format for new product applications (including 
applications for biotechnology-derived products) for submission to the 
regulatory authorities in the three ICH regions. The M4 CTD guidance 
was made available in four parts as follows: (1) A description of the 
organization of the M4 CTD; (2) the Quality section; (3) the Safety, or 
nonclinical, section; and (4) the Efficacy, or clinical, section.
    In September 2002, the ICH Steering Committee agreed that a draft 
guidance entitled ``Common Technical Document--Quality: Questions and 
Answers/Location Issues'' should be made available for public comment. 
The draft guidance is the product of the CTD-Quality Implementation 
Working Group of the ICH. Comments about this draft will be considered 
by FDA and the CTD-Quality Implementation Working Group.
    The draft guidance provides further clarification for preparing the 
quality components of an application in the CTD-Quality format. The 
draft guidance addresses the relationship between linked sections for 
certain parameters, such as polymorphism and particle size. The draft 
guidance also addresses location issues by indicating the section in 
which to place requested information. The draft guidance is intended to 
ease the preparation of paper and electronic submissions, facilitate 
regulatory reviews, and simplify the exchange of regulatory information 
among regulatory authorities.
    This draft guidance, when finalized, will represent the agency's 
current thinking on this topic. 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 (see 
ADDRESSES) written or electronic comments on the draft guidance. Two 
copies of any mailed 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 guidance and received comments may be seen 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 
http://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.

    Dated: December 23, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-32852 Filed 12-27-02; 8:45 am]
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