[Federal Register: February 9, 2005 (Volume 70, Number 26)]
[Notices]
[Page 6888-6889]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09fe05-69]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0021]
International Conference on Harmonisation; Draft Guidance on Q8
Pharmaceutical Development; 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availability of a draft guidance entitled ``Q8 Pharmaceutical
Development.'' The draft guidance was prepared under the auspices of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). This draft
guidance describes the suggested contents for the pharmaceutical
development section in the quality module of a regulatory submission in
the ICH M4 Common Technical Document (CTD) format. The draft guidance
is intended to assist in the development of pharmaceutical studies that
provide scientific understanding to support the establishment of
specifications and manufacturing controls and serve as the basis for
evaluating risk management over the life cycle of the product.
DATES: Submit written or electronic comments on the draft guidance by
April 11, 2005.
ADDRESSES: Submit written comments on the draft guidance to the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
draft guidance may also be obtained by mail by calling the CBER Voice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 your
requests. Requests and comments should be identified with the docket
number found in brackets in the heading of this document. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Ajaz Hussain, Center for Drug Evaluation
and Research (HFD-3), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-594-2847; or Christopher Joneckis, Center for
Biologics Evaluation and Research (HFM-20), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-435-5681.
Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4480.
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 Center for Drug
Evaluation and Research and the Center for 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.
During the July 2003 ICH meeting in Brussels, agreement was reached
on a common vision and approach for developing an international plan
for a harmonized pharmaceutical quality system that would be applicable
across the life cycle of a product. This plan emphasizes an integrated
approach to review (assessment) and inspection based on scientific risk
management. One aspect of the plan was the establishment of an expert
working
[[Page 6889]]
group to develop guidance for pharmaceutical development throughout the
life cycle of a product.
In November 2004, the ICH Steering Committee agreed that a draft
guidance entitled ``Q8 Pharmaceutical Development'' should be made
available for public comment. The draft guidance is the product of the
Quality Expert Working Group of the ICH. Comments about this draft will
be considered by FDA and the Quality Expert Working Group.
This document is a significant element in FDA's initiative,
``Pharmaceutical Current Good Manufacturing Practices for the 21
Century,'' which encourages review of current manufacturing science
practices. Scientific information obtained during the design of a
product and from the pharmaceutical development studies is important
for the development and selection of a product formulation that meets
the purpose specified in the product application.
The draft guidance describes the suggested contents for the
pharmaceutical development section (section 3.2.P.2 of module 3:
Quality) of a regulatory submission in the CTD format. The draft
guidance is intended to assist in the development of pharmaceutical
studies that provide scientific understanding to support the
establishment of specifications and manufacturing controls and serve as
the basis for evaluating risk management over the life cycle of the
product.
This draft guidance applies to pharmaceutical studies as defined in
section 3.2.P.2 of module 3 of the CTD. The draft guidance does not
apply to submissions for drug products during the clinical research
stages. However, the principles described in the draft guidance are
important to consider during product development.
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 Division of Dockets Management
(see ADDRESSES) written or electronic comments on this draft 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 draft 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/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://www.fda.gov/cber/publications.htm.
Dated: February 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2449 Filed 2-8-05; 8:45 am]
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