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Regulatory
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EU Parliament Adopts Position on Pharmaceutical Reform: Focus on Regulatory Data and Market Protection Rules
This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click here.
Overview of the Key Changes to Regulatory Data Protection
One of the primary changes—and the focus of considerable debate—is the revision of the rules regarding regulatory data protection. The new Directive's draft text devotes an entire chapter to regulatory data and market protection. You can read our initial article on the Commission’s...
July 15, 2024
3 min read
EU Pharmaceutical Law Revision: Re-Boxing Set to Become...
In April 2024, the European Parliament voted to adopt a revised...
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
EU Parliament Adopts Position on Pharmaceutical Reform:...
On April 10, 2024, the European Parliament voted to adopt a revised...
June 18, 2024
4 min read
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...
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
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