[Federal Register Volume 68, Number 1 (Thursday, January 2, 2003)]
[Notices]
[Pages 126-127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-33075]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0518]


Preparation for International Conference on Harmonisation 
Meetings in Tokyo, Japan, Including Progress on Implementation of the 
Common Technical Document and Update on New Topics

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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SUMMARY: The Food and Drug Administration is announcing the following 
meeting: ``Preparation for ICH Meetings in Tokyo, Japan, February 3 
through 6, 2003, Including Progress on Implementation of the Common 
Technical Document (CTD) and Update on New Topics'' to solicit 
information and receive comments on the International Conference on 
Harmonisation of Technical Requirements for the Registration of 
Pharmaceuticals for Human Use (ICH) as well as the upcoming meetings in 
Tokyo, Japan. The purpose of the meeting is to solicit public input 
prior to the next Steering Committee and Expert Working Group meetings 
in Tokyo, Japan, February 2003, at which discussion of the CTD and the 
future of ICH will continue.
    Date and Time: The meeting will be held on January 21, 2003, from 
10:30 a.m. to 2 p.m. Submit registration material by January 14, 2003.
    Location: The meeting will be held at 5630 Fishers Lane, rm. 1066, 
Rockville, MD 20875.
    Contact Person: Kimberly L. Topper, Center for Drug Evaluation and 
Research, Food and Drug Administration, 5630 Fishers Lane, Rockville, 
MD 20857, 301-827-7001, FAX 301-827-6801, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: The 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, 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 representatives of the observers: WHO, Health Canada and 
the European Free Trade Area. 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 at the following 
Web site: http://www.ich.org.
    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 January 14, 2003.
    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 
11:30 a.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 January 14, 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.

[[Page 127]]

    If you need special accommodations due to a disability, please 
contact Kimberly L. Topper at least 7 days in advance.
    Agenda: The agenda for the public meeting will be made available on 
January 14, 2003, at the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
under docket number 02N-0518.
    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.

    Dated: December 26, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-33075 Filed 12-31-03; 8:45 am]
BILLING CODE 4160-01-S