Food and Drug Administration, HHS.
Notice of meeting.
The Food and Drug Administration (FDA) is announcing a public meeting to provide information and receive comments on the International Conference on Harmonization (ICH) in advance of its next next Steering Committee and Expert Working Group meetings in Brussels, Belgium, May 9 through 12, 2005. Scheduled for the ICH meetings is an Efficacy Brainstorming Session focusing on the review of the existing efficacy guidelines and their need for updating as well as potential new topics for consideration. To promote a fuller discussion of this topic the public meeting will be expanded to include public input on initiatives related to current ICH efficacy guidelines and consider needs for further information both within and between existing guidances. These initiatives include electronic source data, clinical development plan summaries, Health Level 7 structured product labeling, and other initiatives including information exchange standards (e.g., Electronic Common Technical Document (eCTD) and terminology standards).
Date and Time: The meeting will be held on April 20, 2005, from 9 a.m. to 5:30 p.m.
Location: The meeting will be held at The DoubleTree Hotel and Executive Meeting Center, 1750 Rockville Pike, Rockville, MD. A block of rooms for those wishing to attend the meeting have been set aside at the government rate. Please contact the hotel directly for your reservation: DoubleTree Hotel and Executive Meeting Center, 301-468-1100, FAX: 301-468-0308.
Contact Person: Sema Hashemi, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3050, FAX: 301-480-0716, e-mail: Sema.Hashemi@fda.hhs.gov.
Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and FAX number), and written material and Start Printed Page 17699requests to make oral presentations, to the contact person by April 14, 2005.
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.
If you need special accommodations due to a disability, please contact Sema Hashemi at least 7 days in advance.End Preamble Start Supplemental 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 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, 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. 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 we are 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 1 p.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 April 14, 2005, 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 topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting and ICH Expert Working Groups. One of the topics for the upcoming ICH meeting is an Efficacy Brainstorming Session focusing on the review of the existing efficacy guidelines and their need for updating as well as potential new topics for consideration. The complete set of ICH Efficacy Guidelines may be found at http://www.ich.org/ or http://www.fda.gov/cder/guidance/index.htm. To promote a fuller discussion of this topic the public meeting will be expanded to include public input on initiatives related to current ICH efficacy guidelines and consider needs for further information both within and between existing guidances. These initiatives include electronic source data, clinical development plan summaries, Health Level 7 structured product labeling, and other initiatives including information exchange standards (e.g., eCTD and terminology standards).
The agenda for the public meeting will be made available on April 15, 2005, via the internet at http://www.fda.gov/cder/meeting/ICH_Spring2005.htm.Start Signature
Dated: April 1, 2005.
Assistant Commissioner for Policy.
[FR Doc. 05-7020 Filed 4-5-05; 11:53 am]
BILLING CODE 4160-01-S