Carla Schoonderbeek

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[1] This post and the paper it links to were prepared at the instruction of Novartis; it reflects the views of the authors.

Radiopharmaceuticals are a special type of medicinal products. Where they are prepared industrially or by a method involving an industrial process and are intended to be placed on the market in the European Union (‘EU’), they are subject to the rules of Directive 2001/83/EC on medicinal products for human use (the ‘Medicines Directive’). In addition, if patients are treated with radiopharmaceuticals, account should be taken of Directive 2013/59/EURATOM (the ‘Euratom Directive’) which lays down basic standards for the protection of individuals against radiation exposure.Continue Reading Development of a new EMA guideline on the clinical evaluation of ready to use radiopharmaceuticals[1]

Today, 26 April 2023, the European Commission (the Commission) published its long-awaited proposed amendments to the EU regulatory framework for medicinal products (the Proposals). We set out the key takeaways from these Proposals in our Advisory.

This is the culmination of a number of years’ work by the Commission, starting with the new pharmaceutical strategy for Europe (the Strategy) announced on 25 November 2020. We set out a summary of and reasons behind the Strategy in a previous Advisory, noting that the Strategy sought to ensure a high level of public health by increasing the availability, accessibility, and affordability of medicinal products throughout the EU and harmonize the internal market.

To meet these goals, the Commission has proposed substantial changes to the EU regulatory system, via a new Directive that will replace Directive 2001/83 (medicinal products for human use), and a new Regulation that will replace Regulation (EC) No 726/2004 (authorization and supervision of medicinal products), Regulation (EC) No 141/2000 (orphan medicinal products), and Regulation (EC) No 1901/2006 (pediatric medicines). The Proposals include changes to the regulatory protections available for medicinal products and orphan medicinal products and a new procedure relating to shortages of medicinal products. Continue Reading Proposed Amendments to the EU Regulatory Framework for Medicinal Products