Regulatory Protection in the Pharmaceutical and Life Science Industries

This book comprehensively elaborates on the EU framework for regulatory protection in life science industries. Żaneta Zemła-Pacud discusses the rules governing regulatory exclusivities and rewards for both innovative life science products and the regulatory data underlying them. The analysis focuses primarily on pharmaceuticals, such as reference medicinal products, orphan drugs and paediatric medicines, but it also encompasses goods from the agrochemical and food sectors, such as plant protecti