[Federal Register Volume 65, Number 87 (Thursday, May 4, 2000)]
[Notices]
[Pages 25938-25939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11246]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1220]


The Future of the International Conference on Harmonization of 
Technical Requirements for the Registration of Pharmaceuticals for 
Human Use (ICH); Notice of Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``The Future of the International Conference on 
Harmonization of Technical Requirements for the Registration of 
Pharmaceuticals for Human Use'' to solicit information and receive 
comments on the future of the ICH. The purpose of the meeting is to 
solicit public input prior to the next Steering Committee meeting in 
Brussels, Belgium, July 2000, at which discussion of the future of the 
ICH will be continued.

DATES: The public meeting will be held on May 16, 2000, from 10 a.m. to 
2 p.m. Registration must be received by May 9, 2000. Written and 
electronic comments regarding the public meeting must be submitted by 
May 20, 2000.

ADDRESSES: The public meeting will be held in the Center for Drug 
Evaluation and Research, Advisory Committee Conference Room, 5630 
Fishers Lane, rm. 1066, Rockville, MD 20857.
    Written submissions must be sent to the Dockets Management Branch, 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Two copies of any written comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Electronic submissions must be sent to the Dockets 
Management Branch at http://www.fda.gov/scripts/oc/dockets/comments/commentsmain.cfm.

FOR FURTHER INFORMATION CONTACT: 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, or 
e-mail: [email protected].
    Registration: There is no registration fee for this public meeting, 
but registration by May 9, 2000, is required. Participation is limited 
to the first 140 registrants due to limited space. FDA employees are 
required to register to attend the meeting. Interested persons may 
register with the contact person via e-mail at: [email protected] or 
fax 301-827-6801 and provide the following information: Name, 
affiliation, address, phone, fax, and e-mail address. Interested 
persons may also register by mail with the contact person (address 
above).

SUPPLEMENTARY INFORMATION:

I. Background

    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. 
The ICH was organized to provide an opportunity for harmonization 
initiatives to be developed with input from both regulatory and 
industry representatives. The ICH is concerned with harmonization among 
the following 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 and Welfare, the Japanese Pharmaceutical 
Manufacturers Association, 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, the Canadian Therapeutics Products Programme, 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 on the Internet at http://www.ifpma.org/ich1.html.
    The ICH will present the Common Technical Document and other 
significant achievements at the ICH 5 Conference in San Diego in 
November 2000. In preparing for this meeting, the ICH Steering 
Committee is evaluating the future direction for the ICH, including 
structure, processes, work program, and global cooperation. FDA is 
soliciting public input at this time to assist the agency in these 
deliberations.

II. Issues To Be Discussed at the Public Meeting

    The issues to be discussed include the following: (1) 
Administrative and technical issues, (2) future participation, (3) 
global cooperation, and (4) new topic areas.
    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 
10:30 a.m. and 2 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 May 9, 2000, and submit: A brief statement 
of the general nature of the evidence or arguments they wish 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 25939]]

    The full agenda for the public meeting will be available on May 10, 
2000, at the Dockets Management Branch (address above). Requests should 
be identified with the Docket Number 00N-1220.

    Dated: April 28, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-11246 Filed 5-2-00; 11:30 am]
BILLING CODE 4160-01-F