Last week (28 March 2024), the UK Health Research Authority (“HRA”) published a draft model investigator-initiated study agreement (“mIIS-CTA”) to govern investigator-initiated clinical studies (“IIS”) that involve NHS patients and receive support from commercial partners. The HRA is calling for comments on the draft mIIS-CTA by 13 May 2024.
Tune into this episode of Covington’s Life Sciences Audiocast, where Sibel Yilmaz, Majken Lagerbielke, and Leire Garagorri Eguidazu discuss the new market definition notice published by DG COMP, specifically the latest on the new guidance concerning pharmaceutical innovation markets and possible implications for analysing M&A and licensing deals.
Tune into this episode of Covington’s Life Sciences Audiocast, where Winsome Cheung and George Jenkins discuss the key trends in Life Sciences Transactions for 2024. The speakers discuss the outlook for deal-making in Life Sciences and predictions for deal trends, including in relation to nuclear medicine, GLP-1, antibody-drug conjugates and other modalities. The speakers also
The European Union has adopted various new rules for emergency situations relating to public health. These new measures build on the experience gained from the COVID-19 pandemic and give new powers to the European Commission, in close cooperation with the Member States.
The new rules create a complex public health crisis management system. Measures that
The High Court has quashed decisions by the Food Standard Agencies in England, Wales and Scotland (“the FSAs”) that concluded that monk fruit decoctions are a novel food. The Court ordered the FSAs to re-consider their position by assessing all of the evidence submitted to the FSAs on its own merits, rather than the FSAs’
On March 11, 2023, the UK Government published its response (“Government Response”) to an independent review on equity in medical devices commissioned by the Department of Health and Social Care (“Review”). The Government Response is not guidance nor policy rather it is intended to act as an action plan for tackling potential bias in the
A UK judge has decided that Odysea Ltd, an artisan food company, can use the word “raw” to describe its small-batch, minimally‑processed honey. Judge Neville, of the First‑tier Tribunal (General Regulatory Chamber), gave the decision on 26 February 2024. The judgement is available here and opens with a classic reference to Winnie the Pooh:
In an earlier blog, we wrote that the German regulation of pharmaceutical pricing and reimbursement is one of the most complicated legal areas in the entire world of life sciences laws. With the new draft “Medical Research Act” (Medizinforschungsgesetz or MFG) that came out in January 2024, the German government plans to
On 26 January 2024, the European Medicines Agency (EMA) announced that it has received a €10 million grant from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA). Although still in its early stages as an agency, AMA shows significant promise to
Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented the draft for a “Medical Research Act” (Medizinforschungsgesetz or MFG). The draft bill proposes legislative amendments in several areas that span from clinical trials, GMP issues for ATMPs up