The Turkish Pharmaceuticals and Medical Devices Agency (“Agency”) has become a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S leads international development, implementation and maintenance of harmonized Good Manufacturing Practice (“GMP”) standards and systems for medicinal product Inspectorates. The Agency’s GMP inspections will now be globally recognized and Turkey’s membership in the scheme will inevitably improve quality and reliability of local pharmaceutical products. As a result, the Agency expects increased growth in export figures over the upcoming period.
The PIC/S was established in 1995 as an extension to the Pharmaceutical Inspection Convention (“Convention”). The Convention is a non-binding instrument, aiming to support GMP by improving co-operation between regulatory authorities and the pharmaceutical industry. PIC/S currently has 52 members from all around the world, including Switzerland, US, UK, Germany, Canada, Japan and Australia.
The Agency first applied to join PIC/S in 1989, but was declined in 1991 due to failure to meet the membership requirements. After a four-year audit and assessment process, the Agency filed a second application in 2013, which was ultimately successful. The Agency will be a member from 1 January 2018 onward.
Information first published in the MA | Gazette, a fortnightly legal update newsletter produced by Moroğlu Arseven.