
[Federal Register: June 9, 2009 (Volume 74, Number 109)]
[Notices]
[Page 27325-27326]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn09-67]

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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
