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
 

The impact of regulation on the safe use of drugs: overview of the Workshop

Dr Jürgen Beckmann, Germany

The whole system of pharmacovigilance begins with risk identification and assessment. Any drug then has to be evaluated in terms of its benefits against its risks, and in comparison with alternatives. These considerations eventually give rise to regulatory measures. Ideally, a feedback system should be linked to the initial stage to monitor the outcome and evaluate the effectiveness and appropriateness of the measures.

In exercising self-regulation, the pharmacovigilance officer should detect drug-related hazards, assess the risk, eliminate or reduce the hazard, inform health care professionals and consumers on the regulatory measures, and assess the outcome of the measures.

Different sentinels and indicators should be devised and put in place in various sectors of the health care system to obtain feedback on the effects of the regulatory decision. Cooperation among drug regulatory authorities should be encouraged and enhanced, with WHO serving as a facilitator.

Moreover, regulators should give attention to improving their sources of information, the interaction among regulators, and the quality of information exchanged, and consider particular difficult situations with which the feedback system might have to cope.

A number of measures to improve the feedback loop were discussed at the pre ICDRA workshop on The Impact of Regulation on the Safe Use of Drugs. These are:

• Improvement of regulators’ sources of information.
• Improvement in mutual interaction between regulators.
• Improvement in quality of information exchanged.


Some examples of particularly difficult, though relevant, situations with which any feedback based system will have to cope were presented.

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