Posts with tag regulatory

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The Return of Biosimilar Substitution in France
Every year the Social Security Financing Law for 2022 (LFSS 2022) introduces several measures resulting in important changes for the life sciences sector and the health insurance system. One of the recent changes of note include the reintroduction of biosimilar substitution, which will allow pharmacists to substitute a biosimilar for the prescribed (reference) biological under certain conditions. Similar legislation enabling biosimilar substitution has existed previously in France. Introduced by...
March 28, 2022
3 min read
Renewal of early access and compassionate use frameworks...
On 1 July 2021, the early access and compassionate use reform...
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,...
October 7, 2021
4 min read
Worldwide Interpol operation Pangea XIV leads to shutdowns...
Operation Pangea is a yearly recurring operation in which Interpol...
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
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
Post-Transition Brexit: New MHRA Guidelines on Medical Devices
With a post-transition Brexit looming on the horizon, the Medicines and Healthcare products Regulatory...
September 21, 2020
4 min read
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