[Federal Register Volume 70, Number 26 (Wednesday, February 9, 2005)]
[Notices]
[Pages 6888-6889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2449]


-----------------------------------------------------------------------

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International Conference on Harmonisation; Draft Guidance on Q8 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.

-----------------------------------------------------------------------

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availability of a draft guidance entitled ``Q8 Pharmaceutical 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 The draft guidance was prepared under the auspices of 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 This draft 
guidance describes the suggested contents for the pharmaceutical 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 The draft guidance 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DATES:  Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written comments on the draft guidance to the 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://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draft guidance may also be obtained by mail by calling the CBER Voice 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://www.fda.gov/ohrms/dockets/default.htm, 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]
BILLING CODE 4160-01-S