(2002; 166 pages)
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.