[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69634-69635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28142]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0436]


International Conference on Harmonisation; Guidance on Q11 
Development and Manufacture of Drug Substances; 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 ``Q11 Development and Manufacture 
of Drug Substances.'' 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 approaches to developing and understanding the manufacturing 
process of a drug substance and provides guidance on what information 
should be provided in certain sections of the Common Technical Document 
(CTD). The guidance is intended to harmonize the scientific and 
technical principles relating to the description and justification of 
the development and manufacturing process of drug substances (both 
chemical entities and biotechnological/biological entities) to enable a 
consistent approach for providing and evaluating this information 
across the three regions. The discussion of principles in the guidance 
is intended to apply only to the manufacture of drug substance, not the 
manufacture of finished drug products.

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

ADDRESSES: 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, 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

[[Page 69635]]

(CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448. Send one self-addressed adhesive label to assist the 
office in processing your requests. The guidance may also be obtained 
by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance:

John Smith, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 2619, Silver 
Spring, MD 20993-0002, 301-796-1757; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-6210.

    Regarding the ICH:

Michelle Limoli, Center for Drug Evaluation and Research, International 
Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 3342, Silver Spring, MD 20993-0002, 301-796-8377.

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 harmonization 
initiatives to be developed with input from both regulatory and 
industry representatives. FDA also seeks input from consumer 
representatives and other stakeholders. 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 June 29, 2011 (76 FR 38187), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``Q11 Development and Manufacture of Drug Substances.'' The 
notice gave interested persons an opportunity to submit comments by 
September 1, 2011.
    FDA received numerous comments on the draft guidance and those 
comments were considered as the guidance was finalized. After 
consideration of the comments 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 April 2012. 
The final document provides guidance on approaches to developing and 
understanding the manufacturing process of the drug substance and 
provides guidance on what information should be provided in certain 
sections of the CTD. A summary of changes includes the following: (1) 
Revisions to the introduction and process development sections to more 
strongly emphasize that purification processes play a significant role 
in drug substance manufacture, (2) revisions to the discussion of 
design space for chemical entities and biotechnological/biological drug 
substances, and (3) revisions to the discussion of control strategy. In 
addition, editorial changes were made to improve clarity.
    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 either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

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/Guidances/default.htm.

    Dated: November 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28142 Filed 11-19-12; 8:45 am]
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