Pharmaceutical and Medical Devices Institute

The Turkish Medicines and Medical Devices Agency was set up in March 2012 to replace the General Directorate of Pharmaceuticals and Pharmacy under the Ministry of Health. The Agency is responsible for the regulation of four key areas: pharmaceuticals (licensing, risk assessment, pharmacovigilence, pricing, ensuring rational drug use and access to drugs), medical devices, cosmetics and laboratory services. The Agency was established following the 27th Article of Decree Law No. 663, stating its purpose as: “determining the rules and standards for the licensing, manufacturing, storage, sale, import, export, supply, distribution, put into service, seizure and use of products, ... , licensing, auditing and imposing sanctions when necessary”.

Activities include, for example, the “Pharmaceutical Track and Trace System” (ITS), set up on 1 January 2010, to assure “patient safety” and to guarantee that patients have a reliable access to safe drugs. It also aims to prevent fraud, smuggled, counterfeit drugs. A similar track and trace system is being implemented for medical devices which track the location of every medical device (i.e. of each patient) and its outcomes. The Agency also aims to provide product safety, as well as audits, in relation to the promotion and advertising activities associated with pharmaceuticals and medical devices, namely through the “Regulation on Promotion Activities of Medicinal Products for Human Use”. The standardisation of medical devices sales locations and promotion is also planned through the “Medical Device Sales Warehouse and Retail Centers Legislation” regulation.

Figure 1.4. Structure of the Ministry of Health following the 2011 re-organisation

Source: Adapted from World Health Organization (2012), Successful Health System Reforms: The Case of Turkey, WHO Europe, Copenhagen.