ABSTRACT

In our country, medicines entry to the market are evaluated by the Turkish Pharmaceutical and Medical Devices Agency under the responsibility of the Republic of Turkey Ministry of Health. While the medicines market licensing processes of are evaluated, they are evaluated by taking into consideration the international acceptance criteria and the latest scientific developments on effectiveness, safety and quality standards. The licensing processes of biological/biotechnological products, which have importance gradually increased in recent years, have been reviewed taking into account basicly the legislative information.