[Federal Register: June 3, 2003 (Volume 68, Number 106)]
[Notices]
[Page 33163-33164]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn03-87]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0207]
Preparation for ICH Meetings in Brussels, Belgium, and ICH 6
Conference in Osaka, Japan: Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration is announcing a public
meeting entitled ``Preparation for ICH Meetings in Brussels, Belgium,
July 15-18, 2003, and ICH 6 Conference in Osaka, Japan, November 12-15,
2003'' to solicit information and receive comments on the International
Conference on Harmonisation (ICH) as well as the upcoming Meetings in
Brussels, Belgium. The topic to be discussed is the Common Technical
Document, GMPs Initiative and Update on other topics for discussion at
the forthcoming ICH Steering Committee Meeting. The purpose of the
meeting is to solicit public input prior to the next Steering Committee
and Expert Working Group meetings in Brussels, Belgium, July 2003, at
which discussion of the topics underway and the future of ICH will
continue and also to inform the public about the ICH 6 Public
Conference in Osaka, Japan in November 2003.
Date and Time: The public meeting will be held on June 24, 2003,
from 10 a.m. to 1 p.m.
Location: The public meeting will be held at 5630 Fishers Lane, rm.
1066, Rockville, MD 20857.
Contact Person: Kimberly L. Topper, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-7001, FAX 301-827-6801, email:
Topperk@cder.fda.gov. Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
fax number), and written material and requests to make oral
presentations, to the contact person by June 9, 2003.
If you need special accommodations due to a disability, please
contact
[[Page 33164]]
Kimberly Topper at least 7 days in advance.
Transcripts: Transcripts of the meeting may be requested in writing
from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857,
approximately 15 working days after the meeting at a cost of 10 cents
per page.
SUPPLEMENTARY INFORMATION: The International Conference on
Harmonisation of Technical Requirements for the Registration of
Pharmaceuticals for Human Use (ICH) was established in 1990 as a joint
regulatory/industry project to improve, through harmonization, the
efficiency of the process for developing and registering new medicinal
products in Europe, Japan, and the United States without compromising
the regulatory obligations of safety and effectiveness.
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 medical product 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. ICH is concerned with harmonization among
three regions: The European Union, Japan, the United States. The six
ICH sponsors are the European Commission, the European Federation of
Pharmaceutical Industries Associations, the Japanese Ministry of
Health, Labor 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 is provided by the
International Federation of Pharmaceutical Manufacturers Associations
(IFPMA). The ICH Steering Committee includes representatives from each
of the ICH sponsors and Health Canada, the European Free Trade Area and
the World Health Organization. The ICH process has achieved significant
harmonization of the technical requirements for the approval of
pharmaceuticals for human use in the three ICH regions.
The current ICH process and structure can be found on the Internet
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.ich.org.
Interested persons may present data, information, or views orally
or in writing, on issues pending at the public meeting. Oral
presentations from the public will be scheduled between approximately
12:15 p.m. and 1 p.m. Time allotted for oral presentations may be
limited to 10 minutes. Those desiring to make oral presentations should
notify the contact person by June 9, 2003, and submit a brief statement
of the general nature of the evidence or arguments they which to
present, the names and addresses, phone number, fax, and e-mail of
proposed participants, and an indication of the approximate time
requested to make their presentation.
The Agenda for the public meeting will be made available on June 9,
2003, via the internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/calendar/meeting/ich2003
.
Information on the ICH 6 Public Conference in Osaka, Japan on
November 12-15, 2003, can be obtained via the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.ich.org/ich6bis.html
.
Dated: May 28, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13830 Filed 6-2-03; 8:45 am]
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