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
Close this folderRegulatory challenges: health sector reform and drug regulatory capacity
View the documentStrengthening regulatory capacity during reform
View the documentThe creation of a trans-Tasman therapeutic products regulatory agency: a case study in cooperation
View the documentThe South African experience
View the documentDrug registration and importation control in Tunisia
View the documentHealth reform and drug regulation in Venezuela
View the documentEconomic regulation of pharmaceuticals in Brazil
View the documentRecommendations
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
Open this folder and view contentsSafety monitoring
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
 

Drug registration and importation control in Tunisia

Professor Amor Toumi, Tunisia

In developing countries and countries with emerging economies, it is not sufficient for the regulatory authority to ensure safety, quality and efficacy of medicines alone. The authorities should also play a fundamental role with regard to the economic aspects of medicines. Tunisia uses a computerized system with WHO software for drug registration. The system automatically generates all the necessary correspondence, reports and statistics and assists the regulators with decision-making. Another computerized system is used to control the import of drugs. The system is based on close collaboration between the Drug Regulatory Authority and the customs officials, and delivers or refuses permits automatically. It helps the Drug Regulatory Authority in building databases on drug registrations, epidemiological studies, consumption and drug price. With such data, the Drug Regulatory Authority is able to make evidence-based decisions.

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