Posts with tag Legislation

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SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – SoHO establishment authorisation
Legislative process On July 19, 2022, the European Commission introduced a proposal for a regulation focusing on the quality and safety standards of substances of human origin intended for human use (SoHO Proposal). This initiative draws insights from experiences, notably the recent Covid-19 pandemic, and aims to mitigate the risk of disease transmission through blood, tissues, and cells while ensuring an adequate supply. The Council established its negotiating mandate on October 25, 2023. Negotiations...
January 10, 2024
6 min read
Prescribing AI: Contrasting Approaches to AI in Drug...
According to a common quip in the U.S. they innovate on the technology...
October 19, 2023
9 min read
Reform of the EU pharmaceutical legislation: proposals...
This article is part of a series that covers the proposed...
July 10, 2023
4 min read
Proposed reform of the EU pharmaceutical legislation:...
This article is part of a series that covers the proposed...
June 27, 2023
4 min read
Strengthened Environmental Risk Assessment requirements under the proposed new directive on medicinal products for human use
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
June 23, 2023
3 min read
Revamping the European pharmaceutical industry: A closer look at the EU’s proposed legislative framework
On 26 April 2023, the European Commission published the long-anticipated proposal for the revision of...
April 28, 2023
3 min read
The Windsor Framework: One Step Closer to a Single UK market
Following the coming into force of the Windsor Agreement on 25 March 2023, we take a look at what this...
April 3, 2023
5 min read