Posts with tag regulatory

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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...
The SoHO proposal introduces the procedure for obtaining an authorisation...
January 18, 2024
7 min read
HMA-EMA publish multi-annual AI workplan: further guidance...
In December 2023, the joint HMA-EMA Big Data Steering Group (BDSG)...
January 16, 2024
4 min read
Polish government, business associations respond to...
Following the EC's announcement of the European Pharmaceutical...
November 24, 2023
8 min read
Prescribing AI: Contrasting Approaches to AI in Drug Development across the Atlantic
According to a common quip in the U.S. they innovate on the technology front, and the Europeans innovate...
October 19, 2023
9 min read
Circular economy: what impact for healthcare players?
Environmental awareness and the desire to limit or eliminate the impact of human activities on the environment...
September 28, 2023
6 min read
EMA’s envisaged risk-based and human-centric approach to regulate AI
Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal...
September 14, 2023
6 min read
Reforming the European pharmaceutical legislation: Shortages of medicinal products
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
August 7, 2023
5 min read
What does the European Commission’s proposed reform of EU pharmaceutical legislation mean for Paediatric medicines?
This article is part of a series that covers the proposed reforms to EU pharmaceutical...
July 26, 2023
4 min read
Code of practice introduced for holding cultivated meat tastings
Particularly in the Netherlands, developments in the field of cultivated meat have succeeded each other...
July 12, 2023
6 min read