Biotech

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Blood, cells and tissues: regulatory change is coming
Approximately twenty years ago, the regulation of Substances of Human Origin (“SHO”) in Europe was reshaped by the introduction of the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC) (together the “BTC Directives”). Although EU directives are legislative acts, they are not directly binding on Member States and merely set out a goal that all EU countries must achieve. It is up to the particular Member State to determine...
October 25, 2022
5 min read
Spanish Competition Authority analyses distribution...
On June 22, 2022, the Spanish Competition Authority (“CNMC”)...
July 18, 2022
6 min read
Final(ly) Rules of Procedure of the UPC
Apart from the Unified Patent Court Agreement and a large...
July 18, 2022
1 min read
To opt-out or not? The UPC will change the rules of...
Early this year it became clear that the long-pending reform...
June 1, 2022
7 min read
The UPC Committees rule!
Start of the Provisional Application Phase and first committee meetings The Provisional...
April 7, 2022
12 min read
The Return of Biosimilar Substitution in France
Every year the Social Security Financing Law for 2022 (LFSS 2022) introduces several measures resulting...
March 28, 2022
3 min read
International Comparative Legal Guide to Digital Health 2022
Our Life Sciences IP, Regulatory and Data Protection experts Sally Shorthose, Toby Bond, Emma Drake and...
March 17, 2022
1 min read
Impact of Brexit on Artificial Intelligence in Healthcare
AI developments in the UK The UK is starting to uncover significant opportunities...
February 5, 2021
5 min read
Post-Transition Brexit: New MHRA Guidelines on Medicines
With a post-transition Brexit looming on the horizon, the Medicines and Healthcare products Regulatory...
September 30, 2020
7 min read
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