Regulatory

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Blood, cells and tissues: regulatory change is coming
Approximately twenty years ago, the regulation of Substances of Human Origin (“SHO”)...
October 25, 2022
5 min read
Publication of the English version of the new French Clinical Trial Agreement templates
The French legislator recently updated the French clinical trial agreement template also called...
October 10, 2022
2 min read
The Activation of Payback on Medical Devices
The Italian Ministry of Health, in a Decree dated 6 July 2022, certified the overrun of the expenditure...
October 7, 2022
1 min read
Final(ly) Rules of Procedure of the UPC
Apart from the Unified Patent Court Agreement and a large body of further treaties, regulations,...
July 18, 2022
1 min read
Spanish Competition Authority analyses distribution of medicines in Spain
On June 22, 2022, the Spanish Competition Authority (“CNMC”) published a study about the wholesale...
July 18, 2022
6 min read
New Draft Implementing Regulations propose key changes for pharmaceuticals in China
On 9 May 2022, the National Medical Products Administration (the “NMPA”) published the Implementing Regulations...
May 19, 2022
5 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
Renewal of early access and compassionate use frameworks in France
On 1 July 2021, the early access and compassionate use reform entered into force. A medical treatment...
November 10, 2021
6 min read
UK medical devices regime set for an upgrade
Just 7 months after the expiry of the Brexit transition period, the Medicines and Healthcare products...
October 7, 2021
4 min read