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
 

Improving international drug monitoring

Dr Suresh Kumar Gupta, India

There should be greater transparency in the sharing of concerns related to pharmacovigilance between countries. To this end:

• A secure web-based intranet system should be established that will provide information on case reports, clinical data, evidence and proceedings from regulatory decisions.

• WHO should facilitate the sharing of information between countries.

• Systems should be developed to ensure the confidentiality and integrity of shared data.

• Legislation should be enacted to address concerns about privacy and confidentiality.

• Member States should be encouraged to post information, such as regulatory decisions, as soon as possible and preferably before the information is made public.


The database housed in the WHO Collaborating Centre for International Drug Monitoring could be strengthened by the following actions:

• Reviewing the standardization of definitions, harmonization of terminologies and reporting schemes.

• Assigning unique case identifiers to eliminate duplication of reports.

• Advocating for regular and timely reporting of cases by national centres.

• Opening the database primarily to people with legitimate interests in promoting public health and competence in drug safety monitoring.

• Advocating for a global policy statement on the sharing of information on adverse drug reactions and the need for ADR monitoring to override privacy concerns when the public health interest is paramount.


Pharmacovigilance is a truly global activity both in its conduct and impact; WHO-agreed definitions, tools and practices should be regarded as the sole world standards. The current WHO Programme for International Drug Monitoring should be strengthened in its role as the mandated global pharmacovigilance system. All ICH member states should be encouraged to participate actively in the WHO Programme, and contribute to its development. WHO should continue to review regularly the Programme’s definitions, tools, and procedures in the light of developments in safety in medicine, and the work of other groups.

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