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
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Close this folderRegulatory challenges: health sector reform and drug regulatory capacity
View the documentStrengthening regulatory capacity during reform
View the documentThe creation of a trans-Tasman therapeutic products regulatory agency: a case study in cooperation
View the documentThe South African experience
View the documentDrug registration and importation control in Tunisia
View the documentHealth reform and drug regulation in Venezuela
View the documentEconomic regulation of pharmaceuticals in Brazil
View the documentRecommendations
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
 

Recommendations

Health sector reform, especially in developing countries, has been driven more by financial constraints than by health needs. This is an important challenge for drug regulatory authorities that are confronted with reduction in public funding and the need to develop new mechanisms to finance their activities.

Globalization of economies and intensification of international commerce have created new challenges for drug regulatory authorities. Most authorities - especially the less resourced ones - are confronted with regulatory decisions made elsewhere under diverse circumstances.

1. It is in the paramount interest of public health that drug regulation remains a fundamental responsibility of the public sector, is not left to market forces alone, and is not subordinated to commercial interests.

2. New dimensions should be considered in the regulatory assessment of drug quality, safety, efficacy, and information. This must continue to be based on solid scientific evidence, while taking into account the implications of regulatory decisions on public health goals and on access to medicines by the majority of the population.

3. The resources necessary to ensure full regulatory assessment of pharmaceuticals cannot be available to all countries. In order to contribute to strengthening national regulatory capacity, WHO should study existing experience and undertake research in order to develop models for intensified collaboration and, where appropriate, joint decision-making among national regulatory authorities.

4. Availability of information is a crucial tool to achieve appropriate regulatory decisions. WHO should further support national authorities to introduce or improve data management systems in order to produce and interchange information and to achieve evidence-based decision-making.

5. Progress should be reported back to the ICDRA.

 

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