Welcome to our blog dedicated to Life Sciences. We report on EU and national regulatory, compliance, intellectual property and transactional developments in the sector. We focus on (bio)pharmaceuticals and medical technologies, and also cover food and beverages, cosmetics and other healthcare products.
Medical devices industry calls for more time to implement EU Medical Devices Regulation
07 August 2018 - Posted by: Jacqueline Bore
MedTech Europe, the European trade association representing the medical technology industries, has called on the European Commission, European Parliament and EU member states to allow more time for the implementation of the changes to the regulatory scheme for medical devices brought about by the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), › Read More
European Medicines Agency suspends clinical data publication
06 August 2018 - Posted by: Jacqueline Bore
The European Medicines Agency (EMA) announced on 1 August 2018 that, as part of its Brexit business continuity plan, it is temporarily suspending the publication of clinical data submitted to it as part of marketing authorisation applications. Data packages submitted before the end of July 2018 will be processed and formalised but no new procedures will › Read More
02 August 2018 - Posted by: Eveline Van Keymeulen
On 12 July 2018, the French Administrative Supreme Court (Conseil d’Etat) partially annulled Decree No. 2014-1359 insofar as it establishes a general certification obligation for medical prescription assistance software by the High Health Authority (HAS) regardless of its functionalities (Decision n. 387156). The decision follows a December 2017 preliminary ruling of the CJEU in response › Read More
27 July 2018 - Posted by: Steven Baldwin
Those looking for clearer guidance on the practical application of Art 3(a) are likely to be left disappointed by this week’s CJEU judgment in the Teva v Gilead SPC litigation. In summary, the Court (who heard this case in a Grand Chamber of 13 judges) has adopted a Lilly v HGS-based approach to Art 3(a) for combination › Read More
25 July 2018 - Posted by: Sophie ten Bosch
Today, the European Court of Justice (ECJ) has decided in case C-528/16 that organisms obtained by new mutagenesis plant breeding techniques are genetically modified organisms (GMOs) and subject to the obligations laid down in the GMO-Directive (Directive 2001/18/EC). This decision interprets the GMO-Directive in light of new plant breeding techniques such as CRISPR-Cas9. Mutagenesis is › Read More