Life Sciences and Health Care

The United States Food and Drug Administration (“FDA”) has published a guidance on Unique Device Identification System (“Guidance”) to explain … Read more

Turkish Medicines and Medical Devices Agency (“TITCK”) has recently announced that the Turkish Standards Institution (“TSE”) will no longer operate … Read more

Turkish Medicines and Medical Devices Agency (“TITCK”) has announced additional measures to be applied regarding GMP (Good Manufacturing Practices) inspections that take place abroad and certification processes. Additional measures have been taken due to COVID-19 under the TITCK’s decision numbered E.1466 dated June 10, 2020 to prevent setbacks regarding production and provision processes of medicinal products for human use and continuance of market supply.

As per several announcements made by the Ministry of Industry and Technology (“the Ministry”) and Turkish Standards Institute (“TSE”),  COVID-19 Safe Production Quality Certificate (“Certificate”)  to be issued for the companies that fulfill the measures in the Hygiene, Infection Prevention and Control Guide for Industrial Organizations (“Guide”) prepared regarding the measures for the continuation of the production of industrial enterprises in a controlled social life period.

Turkish Medicines and Medical Devices Agency (“TITCK”) has published an updated Guideline on Standard Work Methods of Clinical Research and Bioavailability/Bio-equivalency Studies Ethics Committees, with the purpose to provide supplementary guidance to the current Declaration of Helsinki, the relevant Turkish legislation and good clinical practice principles.

Individualized medical device production on a commercial scale is currently possible with the development of manufacturing technologies including computer-controlled additive and subtractive manufacturing methods based on patient images and digital patient data.

Second medical use claims provide the required protection for originator companies to recoup research investments in therapeutic use based on the original chemical compound. The claim provides additional 20 years protection after the expiry of the original patents that provide product protection for the medical substance.

The race for finding a cure for COVID-19 continues, as more research centers, private enterprises and universities around the globe concentrate on finding an antiviral or vaccine against the virus or providing new solutions for medical equipment manufacturing.

A Pre-Authorization Guide is published by the Turkish Medicines and Medical Devices Agency (“the Agency”) regarding the pre-authorization processes that have been required for the export and import of certain medical products as stipulated by the following communiques

As per the new announcement of Turkish Medicines and Medical Devices Agency (“the Agency”) regarding the Communiqué on the Import of Medical Diagnostic Kits No. 2020/19 (the Communiqué”) published on the Official Gazette dated April 2, 2020 No. 31087; a physical or electronic letter of conformity letter has to be issued by the Agency for the custom procedures of certain human medical diagnostic kits.

Export of medical and surgical masks are now subject to pre-authorization of Ministry of Commerce of Turkey

Tourism mentality has been in a change in the world in recent years. The term “medical tourism” as a part of “alternative tourism” has been taking part also in Turkey. Especially the diversity of natural resources such as thermal waters and investments in