Regulatory

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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
Dutch competition authority ACM imposes EUR 20 million fine on orphan drug manufacturer Leadiant for excessive pricing
The Netherlands Authority for the Consumer and Markets’ ("ACM") announced focus on drug...
July 21, 2021
6 min read
Worldwide Interpol operation Pangea XIV leads to shutdowns and arrests
Operation Pangea is a yearly recurring operation in which Interpol aims to remove the online sale of...
June 24, 2021
2 min read
EU merger control – new guidance brings uncertainty – particularly for tech and pharma acquisitions
Illumina’s acquisition of cancer testing startup, Grail, looks set to be the testing ground for the Commission’s...
April 20, 2021
7 min read
Introduction of the Narcotic Drugs Amendment (Medicinal Cannabis) Bill 2021
On the 3rd February 2021, the Narcotic Drugs Amendment (Medicinal Cannabis) Bill 2021 (Bill) was introduced...
March 2, 2021
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
Hungary: New Legal Provisions set out Mandatory Infrastructure for Telemedicine
Until recently the Hungarian legal background of telemedicine was not particularly detailed. For obvious...
September 29, 2020
4 min read
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