[Federal Register Volume 59, Number 36 (Wednesday, February 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4072]
[[Page Unknown]]
[Federal Register: February 23, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Discussion of Activities of the International Conference on
Harmonisation of Technical Requirements for the Registration of
Pharmaceuticals for Human Use; 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
workshop on the progress of activities associated with the
International Conference on Harmonisation of Technical Requirements for
the Registration of Pharmaceuticals for Human Use (ICH). The agency
will present summary information on guidelines developed as a result of
ICH harmonization initiatives and will respond to questions.
DATES: The workshop will be held on Wednesday, March 2, 1994, 8 a.m. to
5 p.m.
ADDRESSES: The workshop will be held in conference rms. O, P, and Q,
third floor, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Janet Showalter, Office of Health
Affairs (HFY-50), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-1383.
SUPPLEMENTARY INFORMATION: 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 drug development.
ICH is concerned with harmonization of technical requirements for
the registration of pharmaceutical products among three regions: The
European Union, Japan, and the United States. The six ICH sponsors are
the European Union, the European Federation of Pharmaceutical Industry
Associations, the Japanese Ministry of Health and Welfare, the Japanese
Pharmaceutical Manufacturers Association, FDA, and the U.S.
Pharmaceutical Manufacturers Association.
The ICH Steering Committee includes representatives from each of
the organizing bodies and the International Federation of
Pharmaceutical Manufacturers Associations (IFPMA), as well as observers
from the World Health Organization, the Canadian Health Protection
Branch, and the European Free Trade Area. The ICH Secretariat, which
coordinates the preparation of documentation, is provided by IFPMA.
ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from regulatory
and industry representatives and other interested parties. FDA is
committed to ensuring that there is an opportunity for public comment
through Federal Register notices on all of the guidelines developed as
a result of the ICH harmonization initiatives. A number of ICH draft
guidelines will be published soon in the Federal Register for public
comment.
The purpose of this public workshop is to provide an opportunity
for the agency to present summary information about these documents and
to respond to questions. In addition, general background information on
ICH will be provided.
This public workshop should be of interest to professional and
consumer organizations and to the pharmaceutical industry.
The status of the topics under consideration by ICH is as follows:
ICH Consensus Draft Guidelines (will be published in the Federal
Register soon for public comment)
1. Guideline for the Validation of Analytical Procedures
2. Toxicokinetics: A Guidance for Assessing Systemic Exposure in
Toxicology Studies
3. Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution
Studies
4. Dose Selection for Carcinogenicity Studies of Therapeutic Agents
5. Good Clinical Practices: Addenda on Investigators Brochure and
Essential Documents
6. Population Exposure to Assess Clinical Safety
ICH Draft Guidelines and Texts in Preparation
7. Impurities in New Drug Substances (guideline)
8. Light Stability Testing (guideline)
9. Genotoxicity Testing Requirements (guideline)
10. Quality of Biotechnology Products: Genetic Stability
(guideline)
11. Quality of Biotechnology Products: Stability Testing (annex to
guideline on stability testing for new drugs and products)
12. Clinical Study Reports (proposals for a common format based
upon a comparison of current FDA and European Community (EC)
requirements)
13. Ethnic Factors in the Acceptability of Foreign Data (studies
are in progress and a guideline is in preparation)
ICH Consensus Draft Guidelines (released for public comment in the
Federal Register of July 9, 1993)
14. Dose-Response Information to Support Drug Registration
15. Clinical Safety Data Management: Definitions and Standards for
Expedited Reporting
ICH Harmonised Tripartite Guidelines (released for public comment in
the Federal Register of April 16, 1993)
16. Detection of Toxicity to Reproduction for Medicinal Products
17. Studies in Support of Special Populations: Geriatrics
18. Stability Testing of New Drug Substances and Products
Dated: February 17, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-4072 Filed 2-17-94; 3:38 pm]
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