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SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – Preparation Authorisation under the SoHO Proposal
The SoHO proposal introduces the procedure for obtaining an authorisation for SoHO preparations by the introduction of an EU-wide procedure. SoHO preparations are defined as a particular type of SoHO that: (a) has been subjected to one or more SoHO activities, including processing, in accordance with defined quality and safety parameters; (b) meets a pre-defined specification; and (c) is intended for application to a recipient for a specific clinical...
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
AI in healthcare: the World Health Organisation’s regulatory...
The World Health Organisation (WHO) has published regulatory...
December 5, 2023
5 min read
Polish government, business associations respond to...
Following the EC's announcement of the European Pharmaceutical...
November 24, 2023
8 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
AI and the life sciences, navigating the complex legal landscape
Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal...
August 10, 2023
5 min read
EU Commission’s proposed changes to marketing authorisation procedures
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
August 9, 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