[Federal Register: June 9, 2004 (Volume 69, Number 111)]
[Notices]
[Page 32358-32359]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn04-80]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D-0509]
International Conference on Harmonisation; 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 guidance entitled ``M4: The CTD--Quality: Questions
and Answers/Location Issues.'' The guidance was prepared under the
auspices of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
This guidance provides further clarification for preparing the quality
components of an application file in the common technical document
(CTD) format. The guidance addresses the relationship between linked
sections for certain parameters (such as polymorphism and particle
size), and it addresses location issues (by indicating the section in
which to place requested information). The 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 guidance at any
time.
ADDRESSES: Submit written comments on the guidance to the Division of
Dockets Management (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. 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), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The
guidance may also be obtained by mail by calling the CBER Voice
Information System at 1-800-835-4709 or 301-827-1800. Send two self-
addressed adhesive labels to assist the office in processing
[[Page 32359]]
your requests. Requests and comments should be identified with the
docket number found in brackets in the heading of the document. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Justina A. Molzon, Center for Drug
Evaluation and Research (HFD-1), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5400; 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: C. Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0908.
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, and the European Free Trade Area.
In the Federal Register of October 16, 2001 (66 FR 52634), FDA made
available the ICH guidance entitled ``M4 Organization of the Common
Technical Document for the Registration of Pharmaceuticals for Human
Use'' (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: (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 the Federal Register of December 30, 2002 (67 FR 79639), FDA
published a notice announcing the availability of a draft tripartite
guidance entitled ``Common Technical Document--Quality: Questions and
Answers/Location Issues.'' The notice gave interested persons an
opportunity to submit comments by February 28, 2003. 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 in July
2003.
This guidance provides further clarification for preparing the
quality components of an application in the CTD-Q format. The guidance
addresses the relationship between linked sections for certain
parameters, such as polymorphism and particle size. The guidance also
addresses location issues by indicating the section in which to place
requested information. The 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 guidance represents 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 Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance. Submit
a single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. The guidance and received comments may be
seen in the Division of Dockets Management 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/publications.htm, or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: June 3, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-13064 Filed 6-8-04; 8:45 am]
BILLING CODE 4160-01-S