Market Intelligence

The Regulation Amending the Regulation on Manufacturing Facilities for Medicinal Products for Human Use (“Amending Regulation”), published in the Official Gazette dated 21.10.2026 and numbered 33407, introduces amendments to the Regulation on Manufacturing Facilities for Medicinal Products for Human Use (“Regulation”).

A critical consideration before placing health and personal care products on the market is determining their correct regulatory classification. For borderline products – products that may exhibit characteristics of medicinal products, medical devices or cosmetics – this distinction has significant implications for the applicable regulatory requirements, market entry procedures, costs and ongoing compliance obligations.

Turkey's Medicines and Medical Devices Agency has introduced sweeping regulatory reforms across pharmaceuticals, medical devices, and cosmetics sectors. The amendments streamline biosimilar development by eliminating redundant testing requirements, establish new licensing frameworks for herbal products and aromatherapeutic oils, and impose stricter labeling standards for allergens in cosmetics. These changes fundamentally reshape compliance obligations for manufacturers, importers, and healthcare institutio

Türkiye İlaç ve Tıbbi Cihaz Kurumu tarafından yapılan düzenlemeler, biyobenzer ilaçların geliştirilmesini hızlandırırken, tıbbi cihazlar, kozmetik ürünler ve klinik araştırmalara ilişkin...

Turkey's pharmaceutical pricing system undergoes significant transformation with new regulations introducing a 65% Euro/TL conversion rate, incentive mechanisms for first generic products, and the groundbreaking introduction of value-based pricing concepts. The new framework aims to accelerate generic market entry while addressing long-standing challenges in patient access to innovative treatments.

Turkey's pharmaceutical pricing system undergoes a major restructuring with the publication of the New Pricing Communiqué on August 29, 2026, implementing significant changes including increased Euro/TRY conversion rates, incentive mechanisms for first generic market entry, and the introduction of value-based pricing concepts. The new regulations establish detailed provisions for special product categories while leaving certain implementation details to future secondary legislation.