[Federal Register Volume 75, Number 64 (Monday, April 5, 2010)]
[Notices]
[Pages 17148-17149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7593]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0012]
International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 7 on
Dissolution Test General Chapter; 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 ``Q4B Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7:
Dissolution Test General Chapter.'' 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 the results of the ICH Q4B evaluation of the
Dissolution Test General Chapter harmonized text from each of the three
pharmacopoeias (United States, European, and Japanese) represented by
the Pharmacopoeial Discussion Group (PDG). The guidance conveys
recognition of the three pharmacopoeial methods by the three ICH
regulatory regions and provides specific information regarding the
recognition. The guidance is intended to recognize the
interchangeability between the local regional pharmacopoeias, thus
avoiding redundant testing in favor of a common testing strategy in
each regulatory region. This guidance is in the form of an annex to the
core guidance on the Q4B process entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions''
(core ICH Q4B guidance).
DATES: Submit written or electronic comments on agency guidances at
any time.
ADDRESSES: Submit written requests for single copies of the 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. 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. 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.regulations,gov. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Robert H.
King, Sr., Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4150, Silver
Spring, MD 20993-0002, 301-796-1242; 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 (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
[[Page 17149]]
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 February 17, 2009 (74 FR 7447), FDA
published a notice announcing the availability of a draft tripartite
guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 7: Dissolution Test General
Chapter.'' The notice gave interested persons an opportunity to submit
comments by April 20, 2009.
After consideration of the comments received and revisions to the
guidance, a final draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 7: Dissolution Test General Chapter'' was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in October 2009.
The guidance provides the specific evaluation outcome from the ICH
Q4B process for the Dissolution Test General Chapter harmonization
proposal originating from the three-party PDG. This guidance is in the
form of an annex to the core ICH Q4B guidance made available in the
Federal Register of February 21, 2008 (73 FR 9575). When implemented,
the annex will provide guidance for industry and regulators on the use
of the specific pharmacopoeial texts evaluated by the ICH Q4B process.
Following receipt of comments on the draft, no substantive changes were
made to the annex.
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 regarding this document.
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.
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: March 31, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7593 Filed 4-2-10; 8:45 am]
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