[Federal Register Volume 71, Number 98 (Monday, May 22, 2006)]
[Notices]
[Pages 29344-29345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0021]


International Conference on Harmonisation; 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 guidance entitled ``Q8 Pharmaceutical Development.'' 
The guidance was prepared under the auspices of the International 
Conference on Harmonisation of Technical Requirements for Registration 
of Pharmaceuticals for Human Use (ICH). The guidance describes the 
suggested contents for the pharmaceutical development section of a 
regulatory submission in the ICH M4 Common Technical Document (CTD) 
format. The guidance also indicates areas where the provision of 
greater understanding of pharmaceutical and manufacturing sciences can 
create a basis for flexible regulatory approaches.

DATES: Submit written or electronic comments on agency 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://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 CBER 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 guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Moheb Nasr, Center for Drug Evaluation and 
Research (HFD-800), Food and Drug Administration, Bldg. 21, rm. 2630, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1900; 
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 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 February 9, 2005 (70 FR 6888), FDA 
published a notice announcing the availability of a draft tripartite 
guidance entitled ``Q8: Pharmaceutical Development.'' The notice gave 
interested persons an opportunity to submit comments by April 11, 2005. 
To provide additional time for public comment consistent with the time 
for comment provided by other ICH regulatory agencies, FDA reopened the 
comment period until June 11, 2005 (70 FR 24819, May 11, 2005).
    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 November 2005.
    The guidance describes the suggested contents for the 
pharmaceutical development section (section 3.2.P.2) of a regulatory 
submission in the CTD format for drug products as defined in the scope 
of module 3 of the CTD. The information and knowledge gained from 
pharmaceutical development studies provide scientific understanding to 
support the establishment of specifications and manufacturing controls. 
The guidance also indicates areas where the provision of greater 
understanding of pharmaceutical and manufacturing sciences can create a 
basis for flexible regulatory approaches.
    This guidance applies to pharmaceutical studies as defined in 
section 3.2.P.2 of module 3 of the CTD. The guidance does not apply to 
submissions for drug products during the clinical research stages. 
However, the principles described in the guidance are important to 
consider during product development.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The 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

[[Page 29345]]

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 at any 
time. 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://www.fda.gov/ohrms/dockets/default.htm,http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.

    Dated: May 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7727 Filed 5-19-06; 8:45 am]
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