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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.
15 November 2018 - Posted by: David Shen
China’s Ministry of Science and Technology (MOST) recently announced administrative sanctions against six entities for breach of the Provisional Measures for the Administration of Human Genetic Resources (Measure). In the 20 years since the Measure was implemented, this is the first time that MOST has announced any enforcement action. A closer look at the MOST › Read More
12 November 2018 - Posted by: Eveline Van Keymeulen
In October 2018, the French Senate published a report on supply disruptions of medicinal products and vaccines. The report provides recommendations to combat the causes of such disruptions, which have increased by 30% since 2016, and to secure sufficient stock. In particular, the report proposes to: Set up tax exemptions for companies investing in French manufacturing › Read More
08 November 2018 - Posted by: Eveline Van Keymeulen
On 15 October 2018, in preparation for the application of the EU Clinical Trials Regulation, the National Agency for Medicines and Health Products Safety (ANSM) introduced two fast-track procedures to allow faster patient access to innovations. The Clinical Trials Regulation is expected to become applicable in 2020. Fast-track procedure 1, “access to innovation”, aims to › Read More
06 November 2018 - Posted by: Michael Krenz
The Court of Justice of the European Union (CJEU) has ruled that a supplementary protection certificate (SPC) cannot be granted for a medical device comprising an active ingredient because the EU authorisation procedure for devices does not result in a marketing authorisation (MA). The request was made in proceedings brought by Boston Scientific Ltd. and › Read More
30 October 2018 - Posted by: Kaat Van Delm
From the end of October 2018 onwards, companies can apply for publication of their mobile health-applications (mhealth apps) on the governmental website “mhealthbelgium.be“. The website aims to encourage mobile health and make mhealth patient care an integrated pillar of the healthcare sector. It has been created through cooperation among Belgian authorities for food, medicines and › Read More