Regulatory

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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 of the Drug Administration Law (Draft Amendments) (the “Draft Regulations”) for public consultation which will last until 9 June 2022.  The Draft Regulations propose significant changes to the current Implementing Regulations of the Drug Administration Law (2019) (the “Current Regulations”). The Draft Regulations provide a comprehensive regulatory framework governing the entire lifecycle...
May 19, 2022
5 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
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
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