Reform of the EU pharmaceutical legislation got a green light from Estonian Government

On October 19, the Estonian Government endorsed the European Commission's initiative to revamp the pharmaceutical regulation in the EU. This modernisation seeks to catalyse innovation in areas of unmet needs like the development of drugs for rare diseases, children, and antimicrobials. The new regulatory framework also facilitates faster market entry of generic and biosimilar medicinal products. Furthermore, the regulation introduces measures to improve the security of supply of medicinal products by setting clear obligations to economic operators and competent authorities, including the European Medicines Agency.