Alira Health Publishes a White Paper on the Impact of New European Union Regulations on Advanced Therapy Medicinal Product
It provides an overview of the key changes that will impact access to innovative medicines and advanced therapies in the EU.
Advanced Therapy Medicinal Products (ATMPs) are innovative drugs based on genes, cells, and tissues, offering potentially curative treatment options for a variety of diseases. ATMPs are associated with high costs and, in some cases, uncertainties regarding their effectiveness or safety, which currently presents a barrier to market access for these medications.
In 2021, the European Parliament and the Council of the European Union (EU) approved a new EU Health Technology Assessments Regulation (EU HTAR) (Regulation (EU) 2021/2282) to establish common rules and methodologies for HTAs. Then in 2023, the European Commission published a draft of a new EU Pharma Package to revise and replace the existing general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC). This sweeping set of proposals will likely affect numerous aspects of pharmaceutical regulation in the EU.
The white paper Implications of New European Union Regulations on Advanced Therapy Medicinal Products developed by Alira Health provides an overview of the key changes impacting access to innovative medicines in the evolving EU market. It includes detailed information on the EU HTAR and the EU Pharma Package, along with considerations and impacts for manufacturers.