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Hadrien Espiard

Update on the UK’s future medical device regulations: Extended timelines

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has recently announced the introduction...

October 31, 2022

2 min read

Biotech

Phillipus Putter

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

General

Johanna Harelimana

Alexandre Vuchot

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

General

Frederik Haugsted

Badmouthing your competitor’s products: Commission investigation indicates that so-called disparagement claims in the market could be considered stand-alone abuses of dominance

On June 20 2022, the European Commission (“Commission”) published the opening of an...

August 22, 2022

3 min read

General

Federico Marini Balestra

Lucia Antonazzi

Italy: Pharmaceutical company fined by the Italian Competition Authority for the sale of a lifesaving drug at excessive prices

Essetifin S.p.A., Leadiant Biosciences Ltd., Leadiant GmbH and Sigma – Tau Arzenmittel GmbH (“Leadiant”)...

July 18, 2022

6 min read

Biotech

Domien Op de Beeck

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

Biotech

Henri Kaikkonen

To opt-out or not? The UPC will change the rules of the game in the European patent field possibly as soon as next fall

Early this year it became clear that the long-pending reform of the European patent system is finally...

June 1, 2022

7 min read

General

Artificial Intelligence Systems for Medical Diagnosis

The Italian Ministry of Health has published a document on its website entitled “Artificial Intelligence...

May 25, 2022

1 min read

General

China Health and Medical Data Protection (I): Human Genetic Resources Information

I. An Overview of Regulatory Regime Under the Chinese law, human generic resources...

May 24, 2022

13 min read

General

The European Health Data Space Proposal of the European Commission

Unleashing the full potential of health data through facilitating secondary use? On...

May 5, 2022

12 min read

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