Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Close this folderHarmonization II
View the documentRegional harmonization initiatives - the Association of South-East Asian Nations (ASEAN)
View the documentHarmonization in the Americas
View the documentCentralized drug registration system in the Gulf Region
View the documentRecommendations
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Harmonization II

Moderator: Ms Malebona Precious Matsoso, South Africa

It has been stated that the aim of harmonization is to eliminate duplication and to ensure the efficient use of resources in order to allow faster access to safe and effective medicines of good quality. To this end, a number of guidelines have been developed, including those from the ICH. Non-ICH countries have, however, expressed a need to also develop a harmonization process for generic medicines.

A number of regional harmonization initiatives have been developed, and these experiences will be described. There is an understanding that harmonization initiatives should speed up access to medicines, while responding to the forces of international trade and achieving a balance between high technological requirements and public health needs.

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