[Federal Register: December 30, 2002 (Volume 67, Number 250)]
[Notices]
[Page 79639-79640]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30de02-103]
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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International Conference on Harmonisation; Draft Guidance on the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availability of a draft guidance entitled ``Common Technical Document--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 The draft guidance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draft guidance provides further clarification for preparing the quality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 The draft guidance addresses: (1) The relationship between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 The draft guidance is intended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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written comments on the draft guidance to the Dockets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single copies of the draft guidance to the Division of Drug Information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.
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]
BILLING CODE 4160-01-S