```

[Federal Register Volume 73, Number 7 (Thursday, January 10, 2008)]
[Notices]
[Pages 1890-1891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-213]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0493]

International Conference on Harmonisation; Draft Guidance on 
Q8(R1) 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availability of a draft guidance entitled ``Q8(R1) Pharmaceutical 
Development Revision 1.'' The draft guidance was prepared under the 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). 
The draft guidance is an annex to the parent ICH guidance entitled ``Q8 
Pharmaceutical Development'' (71 FR 29344, May 22, 2006) (ICH Q8). It 
provides further clarification of key concepts outlined in ICH Q8 and 
describes the principles of quality by design (QbD). The draft guidance 
is intended to show how concepts and tools (e.g., design space) 
outlined in ICH Q8 could be put into practice by the applicant for all 
dosage forms.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by April 9, 2008.

ADDRESSES: Submit written comments on the draft guidance to the 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 either http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. Submit written requests for single copies of the 
draft guidance to the Division of Drug Information (HFD-240), Center 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 The draft guidance may also 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 CBER at 1-800-835-4709 or 301-827-1800. 
Send two self-addressed adhesive labels to assist the office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance and other guidances mentioned 
in this document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Moheb Nasr, 
Center for Drug Evaluation and Research (HFD-800), 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-20), Food and Drug 
Administration, 1401 Rockville Pike,

[[Page 1891]]

Rockville, MD 20852-1448, 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 IFPMA, as well as observers from the World Health 
Organization, Health Canada, and the European Free Trade Area.
    In November 2007, the ICH steering committee agreed that a draft 
guidance entitled ``Q8(R1) Pharmaceutical Development Revision 1'' 
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.
    The draft guidance is an annex to the parent guidance ICH Q8. It 
provides further clarification of key concepts outlined in ICH Q8 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 ICH Q8 
could be put into practice by the applicant for all dosage forms. Where 
a company chooses to apply QbD and quality risk management (see ICH 
``Q9 Quality Risk Management''), linked to an appropriate 
pharmaceutical quality system (see ICH ``Q10 Pharmaceutical Quality 
Systems''), then opportunities arise to enhance science- and risk-based 
regulatory approaches.
    The draft guidance outlines the elements that should be included in 
pharmaceutical development and additional elements when QbD principles 
are applied. It elaborates, by means of description and example, 
possible approaches to gaining a more systematic, enhanced 
understanding of the product and process under development. The draft 
guidance also provides recommendations on the placement of 
pharmaceutical development and other related information in module 3 of 
a regulatory submission in the common technical document format.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The 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 the 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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.

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: January 2, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-213 Filed 1-9-08; 8:45 am]
BILLING CODE 4160-01-S
```