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
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
Close this folderSafety monitoring
View the documentThe impact of regulation on the safe use of drugs: overview of the Workshop
View the documentSources of information for regulators
View the documentCrisis, pressure and controversy
View the documentImproving international drug monitoring
View the documentRecommendations
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
 

Sources of information for regulators

Dr Benjamin Kwame Botwe, Ghana

Countries should broaden safety monitoring to include medical devices, traditional medicines, homoeopathic medicines, natural health products, lifestyle drugs, rationality of drug use (medication error, poor dispensing practices), and drug quality defects, such as counterfeit drugs.

A multisectoral approach to safety monitoring should be encouraged. Industry, academia, other regulatory bodies, health care professionals, technical agencies such as drug information centres and poisons control centres, consumer groups and patient groups should be involved locally, while international partners, such as WHO/UMC, CIOMS, ICH and other national regulatory agencies should also be involved.

Countries should develop and institutionalize outcome evaluation, feedback mechanisms, appropriate monitoring mechanisms, and success indicators for safety intervention. WHO, together with its Collaborating Centre for International Drug Monitoring, should develop guidelines and assist countries to develop systems for outcome evaluation.

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