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
 

Crisis, pressure and controversy

Dr Stewart Jessamine, New Zealand

Unexpected events that require major regulatory action include product failure, manufacturing error, media interest and overseas regulatory action. Advance planning for such crises is essential, to ensure that sufficient resources are available. Crisis management is multifactorial, and a team of people, each with designated activities, is needed. Advice should be based on the best evidence available; uncertainties and the limitations of information should be acknowledged if they exist, and risk should be placed in the appropriate context. If possible, advice should be sensible, practicable and implementable by health care professionals and consumers alike. Identify target audiences and deliver key messages that are clear, complete and action-oriented. Regulators should also assess the impact of actions and of the communication strategy.

WHO should finalize and distribute its crisis management plans to its Member States. Moreover, countries should develop crisis management plans and test them periodically. WHO should also provide technical assistance and resources in crisis management, communications and research to member countries to develop crisis management plans. Most crises arise from existing adverse reactions, and the seeds of future crises can often be found in the data provided for the premarketing evaluation. Regulators should therefore be encouraged to develop postmarketing risk management strategies for products identified at the time of initial evaluation as posing a significant risk. WHO (via the Uppsala Monitoring Centre) should help Member States to identify criteria that indicate a product is likely to pose a significant risk.

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