Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Table of Contents
View the documentINTRODUCTION
View the document1. WHY PHARMACOVIGILANCE?
View the document2. DEFINITION AND AIMS
Open this folder and view contents3. HOW TO START A PHARMACOVIGILANCE CENTRE
Open this folder and view contents4. REPORTING OF ADVERSE DRUG REACTIONS
Open this folder and view contents5. SPECIAL ISSUES IN REPORTING
Open this folder and view contents6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Open this folder and view contents7. ASSESSMENT OF CASE REPORTS
Close this folder8. USE OF THE DATA
View the document8.1 Hypothesis generation and strengthening
View the document8.2 Drug regulation
View the document8.3 Information
View the document8.4 Education and feedback
View the document8.5 Limitations regarding the use of the data
Open this folder and view contents9. RELATIONS WITH OTHER PARTIES
View the document10. OTHER SOURCES OF INFORMATION
View the document11. FUNDING
View the documentREFERENCES
View the documentGLOSSARY
View the documentCAUSALITY CATEGORIES
View the documentWHO CONTACTS
 

8.2 Drug regulation

After approval of a medicinal product, all available domestic and international safety information is continuously monitored by the drug regulatory authority and the pharmaceutical company concerned. Often problems can be solved by adaptation of the approved product information (inclusion of new adverse effects, warnings, or indication changes). Sometimes stronger restrictive actions are needed, with withdrawal of the marketing authorisation as the extreme. For the approval of a given drug in a given country, it may be very helpful to have information on the experiences with the drug in countries where it is already in use (e.g. through collaboration with the Uppsala Monitoring Centre).

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