Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Índice de contenido
Ver el documentoINTRODUCTION
Ver el documento1. WHY PHARMACOVIGILANCE?
Ver el documento2. DEFINITION AND AIMS
Abrir esta carpeta y ver su contenido3. HOW TO START A PHARMACOVIGILANCE CENTRE
Abrir esta carpeta y ver su contenido4. REPORTING OF ADVERSE DRUG REACTIONS
Abrir esta carpeta y ver su contenido5. SPECIAL ISSUES IN REPORTING
Abrir esta carpeta y ver su contenido6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Abrir esta carpeta y ver su contenido7. ASSESSMENT OF CASE REPORTS
Cerrar esta carpeta8. USE OF THE DATA
Ver el documento8.1 Hypothesis generation and strengthening
Ver el documento8.2 Drug regulation
Ver el documento8.3 Information
Ver el documento8.4 Education and feedback
Ver el documento8.5 Limitations regarding the use of the data
Abrir esta carpeta y ver su contenido9. RELATIONS WITH OTHER PARTIES
Ver el documento10. OTHER SOURCES OF INFORMATION
Ver el documento11. FUNDING
Ver el documentoREFERENCES
Ver el documentoGLOSSARY
Ver el documentoCAUSALITY CATEGORIES
Ver el documentoWHO 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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