Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts, etc.: International Conference on Harmonisation
Federal Register: August 14, 2009 (Volume 74, Number 156)
Notices
Page 41144-41145
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr14au09-56
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2009-D-0343
International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 9 on Tablet
Friability General Chapter; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and
Recommendation of Pharmacopoeial Texts for Use in the ICH Regions;
Annex 9: Tablet Friability General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on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 The draft guidance provides the results of the ICH Q4B evaluation of the Tablet Friability General
Chapter harmonized text from each of the three pharmacopoeias (United
States, European, and Japanese) represented by the Pharmacopoeial
Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing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 This draft guidance is the ninth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).
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CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by October 13, 2009.
ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug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 and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448. The guidance may also be obtained by mail by calling the Center for Biologics Evaluation and
Research 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 draft 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert H. King, Sr., Center for Drug
Evaluation and Research (HFD-003), 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:
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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
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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 June 2009, the ICH Steering Committee agreed that a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex 9: Tablet Friability General
Chapter'' should be made available for public comment. The draft guidance is the product of the Q4B Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the Q4B Expert
Working Group.
The draft guidance provides the specific evaluation results from the ICH Q4B process for the Tablet Friability General Chapter harmonization proposal originating from the three-party PDG. This draft guidance is in the form of an annex to the core ICH Q4B guidance. Once finalized, the annex will provide guidance to assist industry and regulators in the implementation of the specific topic evaluated by the
ICH Q4B process.
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.
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Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
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.
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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/AnimalVeterinary/GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm.
Dated: July 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
FR Doc. E9-19528 Filed 8-13-09; 8:45 am
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