Pharmaceuticals

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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
Healthcare research and the GDPR – which legal basis is appropriate?
Establishing the correct legal basis under the GDPR is essential for any project involving use of...
October 4, 2021
13 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
Spanish courts say “no” to the evergreening on data exclusivity of medicines.
Three recent judgments handed down by the Central Administrative Courts Nos. 4, 10 and 2 on 30 March,...
June 14, 2021
8 min read
First medicinal cannabis drug listed on the Australian Pharmaceuticals Benefits Scheme
On 1 May 2021 Epidyolex, the first medicinal cannabis drug product was listed on the Pharmaceutical Benefits...
May 6, 2021
1 min read
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