Life Sciences Newsletter, January 2018
Turkish Medicines and Medical Devices Agency becomes PIC/S member
Dicle Doğan and Mert Özal, Gün + Partners
The Turkish Medicines and Medical Devices Agency published a press release (Turkish language) on its website, announcing that on 1 January 2018, the agency became an official member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). As a consequence of the approved membership, inspections made by the agency should now be acknowledged all around the globe. In addition, because the quality and safety of the pharmaceuticals produced in Turkey are now certified, locally produced pharmaceuticals should be able to enter into the global market without any obstructions.
PIC/S leads the international development, implementation and maintenance of harmonised standards for good manufacturing practices (GMP) and quality systems of medicinal product inspectorates. During the application process, the agency updated its GMP guidelines to harmonise them with the PIC/S GMP guidelines. A PIC/S inspection team consisting of inspectors from the relevant health authorities of Ireland, Switzerland, New Zealand, Argentina and Malaysia visited and inspected the agency in February 2017.
First published by Practical Law, in 01.02.2018