[Federal Register Volume 71, Number 106 (Friday, June 2, 2006)]
[Notices]
[Pages 32105-32106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0288]


International Conference on Harmonisation; Guidance on Q9 Quality 
Risk Management; 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 ``Q9 Quality Risk Management.'' 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 provides 
principles and examples of tools for quality risk management that can 
be applied to all aspects of pharmaceutical quality throughout the 
lifecycle of drug substances, drug products, and biological and 
biotechnological products. The guidance is intended to enable 
regulators and industry to make more effective and consistent risk-
based decisions.

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

[[Page 32106]]


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: H. Gregg Claycamp, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Place, 
Rockville, MD 20855, 301-827-6505; Albinus D Sa, Center for Drug 
Evaluation and Research (HFD-320), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-9044; Anna M. Flynn, Center 
for Biologics Evaluation and Research (HFM-610), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6201; 
or Diana J. Kolaitis, Office of Regulatory Affairs (HFR-NE1), Food and 
Drug Administration, 158-15 Liberty Ave., Jamaica, NY 11433, 718-662-
5612.
    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 August 8, 2005 (70 FR 45722), FDA 
published a notice announcing the availability of a draft tripartite 
guidance entitled ``Q9 Quality Risk Management.'' The notice gave 
interested persons an opportunity to submit comments by October 7, 
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 provides recommendations for a systematic approach to 
quality risk management. The guidance is intended to support other ICH 
quality documents, complement existing quality practices and standards, 
and enable regulators and industry to make more effective and 
consistent risk-based decisions.
    The guidance includes principles and examples of tools for quality 
risk management that can be applied to different aspects of 
pharmaceutical quality throughout the lifecycle of drug substances, 
drug products, and biological and biotechnological products. These 
aspects include development, manufacturing, distribution, inspection, 
and submission/review processes (including the use of raw materials, 
solvents, excipients, packaging and labeling materials in drug products 
and biological and biotechnological products). The guidance is not 
intended to create any new expectations beyond current regulatory 
requirements.
    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 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 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.>
[FR Doc. E6-8573 Filed 6-1-06; 8:45 am]
BILLING CODE 4160-01-S