BioTalk

28 Oct, 2024

EU Pharmaceutical Reform: Update on the proposed changes to paediatric medicinal product legislation

By Phillipus Putter

This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...

24 Nov, 2023

Polish government, business associations respond to EU pharmaceutical law reform

By Andrzej Stelmachowski

Following the EC’s announcement of the European Pharmaceutical Strategy[1], the Polish government and the country’s business associations...

14 Sep, 2023

EMA’s envisaged risk-based and human-centric approach to regulate AI

By Hester Borgers Christian Lindenthal, LL.M. Dr. Nils Lölfing

Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal developments with regard to AI and the...

09 Aug, 2023

EU Commission’s proposed changes to marketing authorisation procedures

By Sophie Vo Sally Shorthose

This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...

12 Jul, 2023

Code of practice introduced for holding cultivated meat tastings

By Emma Stok Sander Wagemakers Hester Borgers +1 more...

Particularly in the Netherlands, developments in the field of cultivated meat have succeeded each other rapidly over the past years....

10 Jul, 2023

Reform of the EU pharmaceutical legislation: proposals to fight against antimicrobial resistance

By Sarah Faircliffe Nour Saab Johanna Harelimana

This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...

04 Jul, 2023

Increased interest in the use of psychedelics as mainstream therapies

By Josh Price

Psychedelics have been under investigation by academics, clinicians and pharmaceutical companies for some time and the momentum and...

27 Jun, 2023

Proposed reform of the EU pharmaceutical legislation: New regime for orphan medicinal products under the proposed regulation

By Anna Koster Hester Borgers Sarah Faircliffe

This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...

23 Jun, 2023

Strengthened Environmental Risk Assessment requirements under the proposed new directive on medicinal products for human use

By Emma Stok Hester Borgers Sarah Faircliffe

This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...

10 May, 2023

Proposed updates to the regulation of medical devices

By Sophie Vo

While it might be challenging for manufacturers of medical devices to navigate the evolving regulations of medical devices in Great...

28 Apr, 2023

Revamping the European pharmaceutical industry: A closer look at the EU’s proposed legislative framework

By Marc Martens Lora Arifagic Kevin Munungu Lungungu

On 26 April 2023, the European Commission published the long-anticipated proposal for the revision of the pharmaceutical legislative...

17 Feb, 2023

The Impact of the NIS2 Directive and the CER Directive for Medical Device Manufacturers and the Healthcare Sector

By Deirdre Kilroy Georgina Parkinson

The rise in the volume of cyber incidents, the war in Ukraine, and the recent pandemic, has increased focus on the risks for medical...

31 Jan, 2023

Guide to EU and UK Pharmaceutical Regulatory Law 2023

By Sally Shorthose

Eighth Edition, Edited by Sally Shorthose The Guide to EU and UK Pharmaceutical Regulatory Law is a unique volume that provides...

15 Jun, 2022

European Commission proposes to change the rules on regulatory data protection for medicines

By Marc Martens Sarah Faircliffe Benedicte Mourisse

This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...