Regulatory

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EU Pharmaceutical Law Revision: Re-Boxing Set to Become the New Normal for Parallel Imports?
In April 2024, the European Parliament voted to adopt a revised version of a new Pharma Directive, part of the European Commission's legislative reform of EU pharmaceutical law. One amendment, which might have slipped under the radar, could significantly alter the current legal framework for parallel imports of pharmaceuticals, eroding the rights of trademark proprietors. This article is part of our series covering the amendments adopted by the European Parliament to the proposed reforms of EU pharmaceutical...
July 11, 2024
5 min read
EU Parliament Adopts Position on Pharmaceutical Re...
On 10 April 2024, the European Parliament adopted its position...
July 9, 2024
2 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 on the use of AI in the medicines lifecycle
In December 2023, the joint HMA-EMA Big Data Steering Group (BDSG) published a multi-annual (2023-2028)...
January 16, 2024
4 min read
AI in healthcare: the World Health Organisation’s regulatory considerations
The World Health Organisation (WHO) has published regulatory considerations on artificial intelligence...
December 5, 2023
5 min read
Polish government, business associations respond to EU pharmaceutical law reform
Following the EC's announcement of the European Pharmaceutical Strategy[1], the Polish government and...
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