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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
Public Procurement for Biological Medicines in Belgium: The Royal Decree of 13 September 2023 opens the door for compulsory tendering when biosimilars enter the market. Can virtue afford to flirt with legality?
Introduction
The Royal Decree of September 13, 2023 (‘RD’), implementing Article 71bis, § 1,...
September 27, 2023
7 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