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For those with an interest in life sciences, the rise to prominence of CRISPR, a transformational development in the field of molecular biology and genetics, has been impossible to ignore.
In this paper we consider how a new generation of VR equipment promises to fundamentally change consumer experiences of virtual environments, including in the Life Sciences sector.
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.
20 March 2018 - Posted by: Jacqueline Bore
The Court of Justice of the European Union has ruled that the holder of a marketing authorisation for a reference medicinal product in a decentralised procedure does have the right the challenge in the courts of the concerned Member States the grant of a marketing authorisation for a generic medicinal product on the basis that › Read More
14 March 2018 - Posted by: Marco de Morpurgo
In the first post of our “Getting ready for the MDR” series, we have a look at the key timelines that manufacturers need to be aware of as they prepare for the application of the EU Medical Devices Regulation (MDR). Time is going by fast and the new MDR will soon become applicable. Its application › Read More
08 March 2018 - Posted by: Iradj Nazaryar
On 9 February 2018, the Dutch government issued a press release announcing the Council of Ministers’ approval of a proposal for the reimbursement of medicines from abroad that are not (yet) registered in the Netherlands (i.e., replacement medicines). In case of any shortage of a certain medicinal product in the Netherlands, an equivalent medicine approved › Read More
06 March 2018 - Posted by: Veerle Pissierssens
The Belgian Minister of Health has announced in a press release that she is seeking to integrate mobile medical applications (e-health apps) into the Belgian healthcare system. In order to ensure the quality of such e-health apps and the safety of patients, these apps will be evaluated under a specific scheme (Evaluation Scheme) and some › Read More
01 March 2018 - Posted by: Eveline Van Keymeulen
Last week, the French National Agency for Medicines and Health Products Safety (ANSM) published its final recommendations for applicants and holders of marketing authorisations (MA) on the choice of medicinal product names (the Recommendations). The Recommendations were issued following a public consultation by the ANSM in October-November 2016 (see our previous blog post: ANSM opens › Read More