World Health Organization : Year 1993 ; Global Programme on Aidsgpa Res 93.7: Report of the Meeting on International Regulatory Harmonization for HIV/AIDS Drugs and Vaccines

By J. F. Dunne, Dr.

Book Id: WPLBN0000096382
Format Type: PDF eBook
File Size: 0.7 MB
Reproduction Date: 2005

Title:	World Health Organization : Year 1993 ; Global Programme on Aidsgpa Res 93.7: Report of the Meeting on International Regulatory Harmonization for HIV/AIDS Drugs and Vaccines
Author:	J. F. Dunne, Dr.
Volume:
Language:	English
Subject:	Health., Public health, Wellness programs
Collections:	Medical Library Collection, World Health Collection
Historic Publication Date:
Publisher:	World Health Organization


Citation APA MLA Chicago Dunne, Dr, J. F. (n.d.). World Health Organization : Year 1993 ; Global Programme on Aidsgpa Res 93.7. Retrieved from http://gutenberg.cc/

Description
Medical Reference Publication

Excerpt
A Meeting on International Regulatory Harmonization for HIVIAIDS Drugs and Vaccines, cosponsored by the Global Programme on AIDS (GPA) and the Division of Drug Management and Policies (DMP) of the World Health Organization (WHO), was held in Geneva from 29 to 30 Sune 1993. The meeting was attended by a total of 23 participants, including representatives from major drug regulatory authorities from Europe, Japan and North America, and from a drug regulatory authority in a developing country; from the Commission of the European Communities (EC), and from the pharmaceutical indusq and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) (see annex for list of participants).

Table of Contents
CONTENTS 1 . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2 . Status report on the progress of harmonization through the International Conference on Harmonization (ICH) . . . . . . . . . . . . . . . . . . . 2 3 . Accelerated development and approval of new drugs and vaccines for HIVIAIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 (a) Industry's experience: case histories . . . . . . . . . . . . . . . . . . . . . . . . . . 3 (b) WHO'S view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 4. WHO-supported HIV drug and vaccine evaluation sites . . . . . . . . . . . . . . 10 5 . Accelerated development and evaluation of drugs and vaccines for HIVIAIDS: the point of view of regulatory authorities . . . . . . . . . . . . . 11 (a) The US Food and Drug Administration . . . . . . . . . . . . . . . . . . . . . . . 11 (b) Ministry of Health and Welfare. Japan . . . . . . . . . . . . . . . . . . . . . . . . 11 (c) Commission of the European Communities . . . . . . . . . . . . . . . . . . . . 12 (d) The Health Protection Branch of Canada . . . . . . . . . . . . . . . . . . . . . . 13 (e) Drugs Control Council. Zimbabwe . . . . . . . . . . . . . . . . . . . . . . . . . . 14 6 . Conclusions and recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 7 . Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Annex: List of participants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17