[Federal Register Volume 74, Number 109 (Tuesday, June 9, 2009)]
[Notices]
[Pages 27325-27326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-13374]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0148] (formerly Docket No. 2007D-0493)


International Conference on Harmonisation; Guidance on Q8(R1) 
Pharmaceutical Development; Addition of Annex; 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(R1) 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 ICH Q8(R1) 
guidance includes the previously published parent guidance entitled 
``Q8 Pharmaceutical Development'' (Q8 parent guidance) (71 FR 29344; 
May 22, 2006) and a newly added annex. The annex provides

[[Page 27326]]

further clarification of key concepts outlined in the Q8 parent 
guidance and describes the principles of quality by design (QbD). The 
annex is intended to show how concepts and tools (e.g., design space) 
outlined in the Q8 parent guidance could be put into practice by the 
applicant for all dosage forms.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002, or the Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, 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. 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.regulations.gov. 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
21, rm. 2630, Silver Spring, MD 20993-0002, 301-796-1900; or
    Christopher Joneckis, Center for Biologics Evaluation and Research 
(HFM-25), Food and Drug Administration, 1401 Rockville Pike, suite 200, 
Rockville, MD 20852-1448, 301-827-0373.
    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 January 10, 2008 (73 FR 1890), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``Q8(R1) Pharmaceutical Development Revision 1.'' The notice 
gave interested persons an opportunity to submit comments by April 9, 
2008.
    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 2008. Revisions were made in response to comments 
received by the three ICH regions to better express the original intent 
of the draft.
    The annex added to the Q8 parent guidance provides further 
clarification of key concepts outlined in the Q8 parent guidance and 
describes the principles of QbD. The annex is not intended to establish 
new standards or increase regulatory expectations. It is intended to 
show how concepts and tools (e.g., design space) outlined in the Q8 
parent guidance could be put into practice by the applicant for all 
dosage forms. Following the addition of the annex to the Q8 parent 
guidance, ICH recoded the parent guidance Q8(R1).
    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 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 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. 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.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: May 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13374 Filed 6-8-09; 8:45 am]
BILLING CODE 4160-01-S