Regulation of Medicines by the European Medicines Agency (EMA) The European Medicines Agency (EMA) is the regulatory body of the European Union responsible for the scientific evaluation and supervision of medicines developed for commercialization in the European market. Its operations are governed by Directive 2001/83/EC and Regulation 726/2004, which establish the requirements and procedures for […]
Regulatory Reliance in Chile: A Step Forward in the Evaluation of Biological Medicines The Institute of Public Health of Chile (ISP) has implemented a regulatory reliance mechanism for granting health registrations for biological pharmaceutical products. This procedure, formalized through Exempt Resolution No. E679/25 on January 27, 2025, allows the National Medicines Agency (ANAMED) to use […]