03-26283. Preparation for the International Conference on Harmonisation Meetings and ICH 6 Conference in Osaka, Japan; Public Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of meeting.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public meeting entitled “Preparation for ICH Meetings and ICH 6 Conference in Osaka, Japan, November 9-15, 2003” to provide information and receive comments on the International Conference on Harmonisation (ICH) as well as the upcoming meetings in Osaka, Japan. The topics to be discussed are the 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 Experts Working Groups meetings and ICH 6 Public Conference in Osaka, Japan, November 2003, at which discussion of the topics underway and the future of ICH will continue.

Date and Time: The meeting will be held on November 3, 2003, from 1 p.m. to 4 p.m.

Location: The meeting will be held at 5600 Fishers Lane, 3d floor, Twinbrook Conference Room, Rockville, MD 20857.

Contact Person: Christelle Anquez, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20817, 301-827-0037, FAX: [phone], e-mail: [e-mail].

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 October 24, 2003. If you need special accommodations due to a disability, please contact Christelle Anquez 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 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, and 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 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 at the following Web site: http://www.ich.org (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register).

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 3:15 p.m. and 4 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 October 24, 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 October 17, 2003, via the Internet at http://www.fda.gov/​cder/​calendar/​meeting/​ich2003/​nov3meeting.htm.

Information on the ICH 6 Public Conference in Osaka, Japan on November 12-15, 2003, can be obtained via the internet at http://www.ich.org/​ich6tris.html (FDA has verified the Web site address, but is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register).

Dated: October 9, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.