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North Macedonia, as a European Union country candidate, progresses toward integrating with the European Union’s regulatory and economic systems. As these frameworks grow more complicated, the country is tasked with continuously aligning its local industry with European and global standards.

The topic of genetically modified organisms (GMOs) has lately become an actual and increasingly important aspect in Moldovan law. Until recently scarcely regulated, the activity involving GMOs was subject to significant legal loopholes. This led to the inherent risk pertaining to GMOs being difficult to control, especially with agriculture playing an important role in the national economy.

On May 28, 2024, the Turkish Medicines and Medical Devices Agency (Agency) took a significant step in regulating the healthcare industry by unveiling the draft Regulation on Promotional Activities of Medicinal Products for Human Use and Foods for Special Medical Purposes (Draft). This comprehensive Draft aims to address various aspects of promotional activities, ensuring that they are conducted in a manner that upholds scientific integrity and prioritizes patient safety.

Dorda, working with McDermott Will & Emery and Quinz, has successfully advised P95 on its acquisition of the Austrian CRO Assign DMB. 

With a growing economy but significant structural deficits, Romania’s healthcare system struggles with underfunding, slow approval processes, and high taxes, making access to new therapies a slow and challenging endeavor, according to Tuca Zbarcea & Asociatii Managing Associate and Head of Pharma and Medical Devices Dominic Morega.

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