BioTalk

Introduction On March 11, 2025, the European Commission introduced the Critical Medicines Act (CMA), a legislative proposal that...

In 2023, the European Commission proposed a comprehensive update of the key EU pharmaceutical legislation (the "Pharma Package") to...

On 4 June 2025, the Council of the European Union adopted its mandate for negotiations with the European Parliament on two European...

On 12 December 2024, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024  were laid before Parliament. These were...

On 5 March 2025, the European Health Data Space (EHDS) Regulation was officially published in the Official Journal of the European Union....

A recent EU directive will have significant consequences for Australian life sciences companies operating in Europe. Directive 2024/2853...

* This article was co-authored with Olivia Zhao from Bird & Bird Lawjay Shanghai association team.  On 3 January 2025, the General Office...

The Dutch Medicines Evaluation Board (MEB) has recently published a new policy for Compassionate Use Programmes (CUP).[1] To support the...

On 23 December 2024, the Brussels enterprise court issued a first decision in Belgium on the so-called “SPC manufacturing waiver”. Under...

On 9 September 2024 the European Medicines Agency (“EMA”) issued its final reflection paper on the use of AI in the medicinal product...

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have announced a significant update to their guidance on...

Companies in the life sciences sector and its sub-sectors, including pharmaceuticals, medical devices, diagnostics and services, are...

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

On 24 September, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced fines totalling €8 million...

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

On 18 July 2024 President Von der Leyen laid down the path for the next European Commission in her Political Guidelines for the next...