
[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Pages 38187-38188]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16255]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


International Conference on Harmonisation; Draft Guidance on Q11 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availability of a draft guidance entitled ``Q11 Development and 
Manufacture of Drug Substances.'' The draft guidance was prepared under 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 The draft guidance describes approaches to developing 
process and drug substance understanding and provides guidance on what 
information should be provided in certain sections of the Common 
Technical Document (CTD). The draft guidance is intended to harmonize 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.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 1, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. Send one self-addressed adhesive label to assist the office in 
processing your requests. The draft guidance may also be obtained by 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 draft 
guidance document.
    Submit electronic comments on the draft 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
    Christopher Joneckis, Center for Biologics Evaluation and Research 
(HFM-25), Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448, 301-827-0373.

Regarding the ICH

    Michelle Limoli, Office of International Programs, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 3506, Silver 
Spring, MD 20993-0002, 301-796-4600.

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

[[Page 38188]]

observers from the World Health Organization, Health Canada, and the 
European Free Trade Area.
    In May 2011, the ICH Steering Committee agreed that a draft 
guidance entitled ``Q11 Development and Manufacture of Drug 
Substances'' should be made available for public comment. The draft 
guidance is the product of the Q11 Expert Working Group of the ICH. 
Comments about this draft will be considered by FDA and the Q11 Expert 
Working Group.
    The draft guidance describes approaches to developing process and 
drug substance understanding, and provides guidance on what information 
should be provided in sections 3.2.S.2.2 through 3.2.S.2.6 of the CTD. 
The draft guidance provides further clarification on the principles and 
concepts described in ICH guidances ``Q8 Pharmaceutical Development,'' 
``Q9 Quality Risk Management,'' and ``Q10 Pharmaceutical Quality 
Systems'' as they pertain to the development and manufacture of drug 
substance. The guidance is applicable to drug substances as defined in 
the ``Scope'' sections of ICH guidances ``Q6A Specifications: Test 
Procedures and Acceptance Criteria for New Drug Substances and New Drug 
Products: Chemical Substances'' and ``Q6B Specifications: Test 
Procedures and Acceptance Criteria for Biotechnological/Biological 
Products.'' The draft guidance is intended to harmonize the scientific 
and technical principles relating to the description and justification 
of the development and manufacturing process (CTD sections 3.2.S.2.2. 
through 3.2.S.2.6) 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.
    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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

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: June 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16255 Filed 6-28-11; 8:45 am]
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