Posts with tag Europe

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SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – SoHO establishment authorisation
Legislative process On July 19, 2022, the European Commission introduced a proposal for a regulation focusing on the quality and safety standards of substances of human origin intended for human use (SoHO Proposal). This initiative draws insights from experiences, notably the recent Covid-19 pandemic, and aims to mitigate the risk of disease transmission through blood, tissues, and cells while ensuring an adequate supply. The Council established its negotiating mandate on October 25, 2023. Negotiations...
January 10, 2024
6 min read
Code of practice introduced for holding cultivated...
Particularly in the Netherlands, developments in the field of...
July 12, 2023
6 min read
A Guide to the UPC and the UP
The opening of the Unified Patent Court (UPC) on 1 June 2023...
June 9, 2023
2 min read
Revamping the European pharmaceutical industry: A closer...
On 26 April 2023, the European Commission published the long-anticipated...
April 28, 2023
3 min read
Single-arm clinical trials: EMA launches consultation
In contrast to randomised controlled trials (RCTs), single-arm clinical trials (SATs) are relatively...
April 26, 2023
2 min read