[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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