On 19 December 2022, the parties to the Convention on Biological Diversity (CBD) decided to create a new global mechanism requiring the private sector to pay into a new Global Biodiversity Trust Fund.
The new fund is expected to
Latest from Inside EU Life Sciences
UK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media
On 26 January 2023, the UK’s Prescription Medicines Code of Practice Authority (“PMCPA”) published its “Social Media Guidance 2023” (the “Guidance”).
The Guidance is the first of its kind in the UK and is long-awaited.
The PMCPA is
CJEU Rules on the Advertising of “Unspecified Medicinal Products” in the EU
On 22 December 2022, the Court of Justice of the European Union (CJEU) — sitting in Grand Chamber — published its judgement in case C-530, Euroaptieka. The judgement adds further commentary to the meaning of “advertising medicinal products” in
European Commission proposes significant changes to transition timelines of the Medical Device Regulation and IVD Regulation
Further to our discussion on the European Commission’s proposal to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the Commission has adopted a formal proposal for a legislative amendment of the MDR and In Vitro Diagnostic
Outcome from COP 15: a New Global Biodiversity Fund Paid For by Life Sciences Companies that “Use Digital Sequence Information on Genetic Resources”
A snapshot by yours truly while following the debate on synthetic biology. As you can see, business gets a seat in a place far, far away – in the back of the room.
After two weeks of intense negotiations in
New Guidance on the Application of Article 97 of the MDR to Legacy Devices Certified under the MDD or AIMDD
It’s all happening in the device space. Further to the European Commission’s meeting we discussed last week on the proposed three-year extension to the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the EU Medical Device Coordination Group
European Commission Announces Intention to Introduce Three-Year Extension to the MDR Transition Period
The European Commission intends to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR) for an additional three years. The proposal comes among concerns with the number of devices yet to transition to the MDR, along with
CJEU clarifies the Food for Special Medical Purposes Definition
On the 27 October 2022, the Court of Justice of the EU (“CJEU”) issued a preliminary ruling regarding the definition of foods for special medical purposes (“FSMP”). The CJEU held that for a food product to be classified as an
Germany significantly tightens Drug Pricing and Reimbursement Laws
The German regulation of pricing and reimbursement of pharmaceuticals is probably one of the most complicated legal areas in the entire world of life sciences laws. Now, the German government is adding another layer of complexity to the existing rules.
Change is Coming for Software and AI Medical Devices in the UK
The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”). On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency