Healthcare & Life Sciences Newsletter

Published: 2023-09-11 10:13:09 ET HCSG

The Turkish Pharmaceuticals and Medical Devices Authority ("TITCK") recently published the Regulation on Promotion and Information Activities in Healthcare Services.

The TITCK also amended the Guideline on Phase 1 Clinical Research Centers and the Guideline on Application for Good Clinical Practice Audits. In addition, the Presidency amended the Decree on the Pricing of Pharmaceuticals.

Decree on the Pricing of Pharmaceuticals

On 23 July 2023, the Presidency published the Decree Amending the Decree on the Pricing of Pharmaceuticals. The main amendments introduced by the Decree are as follows:

The Decree is available here (in Turkish).

Regulation on Promotion and Information Activities in Healthcare Services

On 29 July 2023, the Ministry of Health published the Regulation on Promotion and Information Activities in Healthcare Services. The main developments introduced by the Regulation are as follows:

The Regulation is available here (in Turkish).

Guideline on Phase 1 Clinical Research Centers

On 31 July 2023, the TITCK updated the Guideline on Phase 1 Clinical Research Centers. In this regard, the regulations regarding phase 1 clinical research centers to be conducted with patient volunteers were updated. The main amendments introduced by the Guideline are as follows:

The Guideline is available here (in Turkish).

Guideline on Application for Good Clinical Practice Audits

On 2 August 2023, the TITCK updated the Guideline on Application for Good Clinical Practice Audits. In this regard, the regulations on the processes related to the issuance, suspension and revocation of activity authorization certificates were updated. The main amendments introduced by the Guideline are as follows:

The Guideline is available here (in Turkish).

Conclusion

The TITCK continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the TITCK's announcements and take necessary actions to ensure compliance.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Mr Can SozerEsin Attorney Partnership Ebulula Mardin Cad. Gul Sok. No. 2Maya Park Tower 2 Akatlar - Besiktas 34335IstanbulTURKEY Tel: 2123398100 Fax: 2123398181 E-mail: [email protected] URL: www.esin.av.tr/