Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages) View the PDF document
Table of Contents
Open this folder and view contentsOpening Ceremony
Open this folder and view contentsGood regulatory practice
Open this folder and view contentsGood certification practice
Open this folder and view contentsCounterfeit drugs: challenges and solutions
Open this folder and view contentsCurrent issues in regulation and quality
Open this folder and view contentsInternational Conference on Harmonization: implementation and implications
Open this folder and view contentsDrug utilization studies
Open this folder and view contentsInternational Conference on Harmonization and the common technical document
Open this folder and view contentsKeynote address
Open this folder and view contentsGlobal and national efforts to reduce tobacco use
Open this folder and view contentsElectronic communication in the regulatory process
Close this folderTransparency in monitoring the safety of medicines
View the documentSignal generation
View the documentSafety issues - lessons learnt
View the documentResponse to a drug alert situation
View the documentPrinciples of risk communication
View the documentExisting mechanisms of information exchange
View the documentRecommendations
Open this folder and view contentsPharmaceutical products for use in special groups
Open this folder and view contentsNeed for Bioequivalence
Open this folder and view contentsAntimicrobial resistance: battling the bugs
Open this folder and view contentsSafety issues of plasma-derived medicinal products
Open this folder and view contentsHerbal medicines
Open this folder and view contentsRegulation and access to essential drugs
View the documentParticipants
View the documentBack cover
 

Recommendations

1. Countries setting up systems for drug safety monitoring should make use of existing experience, including that from WHO and other countries. In this way, scientific resources can be harnessed.

2. Networks for electronic exchange of drug information, in particular relating to safety and which allow for rapid communication, should be established. WHO should take the lead in this endeavour.

3. Regulators should be prepared for crises and guidelines should be available on how to manage a crisis situation involving drug safety.

4. Plans for post-marketing surveillance should be made during drug development.

5. All relevant stakeholders need to be involved in drug safety issues identified by drug monitoring.

6. New drug safety monitoring programmes can be instrumental in the detection of counterfeit drugs, unexpected “lack of efficacy” should be considered and managed as an adverse drug reaction.

7. Authorities should cooperate with other regional authorities when important signals are detected in order to ensure the earliest possible awareness.

8. Principles of good communication should be developed by WHO with input from WHO Member States and regional authorities.

 

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Last updated: April 24, 2012