Regulatory

Sort by Latest
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?
In general The Royal Decree of September 13, 2023 (‘RD’), implementing Article 71bis, § 1, of the Belgian Act on Compulsory Health Care Insurance and Benefits (‘Wet betreffende de verplichte verzekering voor geneeskundige verzorging en uitkeringen’), which establishes specific regulations for public procurement concerning biological medicines, was published in the Belgian Official Gazette on September 22, 2023. The impact of this Royal Decree on the sector could be significant,...
September 27, 2023
7 min read
EMA’s envisaged risk-based and human-centric...
Bird & Bird’s international life sciences and healthcare...
September 14, 2023
6 min read
AI and the life sciences, navigating the complex legal...
Bird & Bird’s international life sciences and healthcare...
August 10, 2023
5 min read
EU Commission’s proposed changes to marketing authorisation...
This article is part of a series that covers the proposed...
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
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
Proposed reform of the EU pharmaceutical legislation: New regime for orphan medicinal products under the proposed regulation
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
June 27, 2023
4 min read
Strengthened Environmental Risk Assessment requirements under the proposed new directive on medicinal products for human use
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
June 23, 2023
3 min read
European Commission proposes to change the rules on regulatory data protection for medicines
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
June 15, 2023
4 min read
Proposed updates to the regulation of medical devices
While it might be challenging for manufacturers of medical devices to navigate the evolving regulations...
May 10, 2023
3 min read