Posts with tag Legislation

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SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – interplay with the Advanced Therapy Medicinal Products (‘ATMP’) Legislation
Legislative process On 19 July 2022, the European Commission (‘EC’) submitted a proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application (‘SoHO Proposal’) to enhance safety standards for human substances, repealing the current Blood, Tissues and Cells (‘BTC’) legislative framework. The Current BTC legislative framework consists of the Blood Directive (Council Directive 2002/98/EC of 27 January 2003 setting standards of quality...
May 8, 2024
6 min read
SOHO ALERT: A Comprehensive Guide to the Proposed Regulation...
Legislative process On July 19, 2022, the European Commission...
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: New regime for orphan medicinal products under the proposed regulation
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
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