7/8/2025 8:00:47 AM EU Pharmaceutical Law Reform: Key Changes on Advertising of Medicinal Products By Kevin Munungu In 2023, the European Commission proposed a comprehensive update of the key EU pharmaceutical legislation (the "Pharma Package") to...
6/20/2025 11:08:08 AM Council of the European Union adopts position on EU pharma package By Benedicte Mourisse Marc Martens Sarah Faircliffe On 4 June 2025, the Council of the European Union adopted its mandate for negotiations with the European Parliament on two European...
5/28/2025 3:09:47 PM UK Clinical Trials Regulations Overhaul By Pieter Erasmus On 12 December 2024, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 were laid before Parliament. These were...
3/31/2025 10:23:09 AM Health Data Holders’ obligations under the EHDS: What, When, and How Will We Know. By Benedicte Mourisse Marc Martens On 5 March 2025, the European Health Data Space (EHDS) Regulation was officially published in the Official Journal of the European Union....
2/19/2025 2:57:21 PM Increased risks for Australian life sciences businesses under the EU’s modernised product liability regime By Rebecca Currey Tom Johnston A recent EU directive will have significant consequences for Australian life sciences companies operating in Europe. Directive 2024/2853...
2/11/2025 8:39:19 AM Strengthening Pharma IP: China’s Boost to Data and Market Exclusivity By Alison Wong * This article was co-authored with Olivia Zhao from Bird & Bird Lawjay Shanghai association team. On 3 January 2025, the General Office...
1/30/2025 9:28:21 AM New Policy for Compassionate Use Programs By Hester Borgers Maud van Haaren The Dutch Medicines Evaluation Board (MEB) has recently published a new policy for Compassionate Use Programmes (CUP).[1] To support the...
1/29/2025 11:15:40 AM First decision on the SPC manufacturing waiver by the Belgian courts By Domien Op de Beeck Camille Vanpeteghem On 23 December 2024, the Brussels enterprise court issued a first decision in Belgium on the so-called “SPC manufacturing waiver”. Under...
1/22/2025 11:28:54 AM EMA’s finalised reflection paper on the use of AI By Hester Borgers Maud van Haaren On 9 September 2024 the European Medicines Agency (“EMA”) issued its final reflection paper on the use of AI in the medicinal product...
1/13/2025 11:15:48 AM EMA and HMA Update Guidance on Commercially Confidential Information in Marketing Authorisation Applications By Benedicte Mourisse Marc Martens The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have announced a significant update to their guidance on...
11/13/2024 1:39:46 PM M&A in Life Sciences By James Baillieu Companies in the life sciences sector and its sub-sectors, including pharmaceuticals, medical devices, diagnostics and services, are...
10/28/2024 12:00:05 PM 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...
10/14/2024 9:22:12 AM Fight against medicine shortages: the French Medicines Agency (ANSM) imposes fines totalling €8 million By Caroline Arrighi-Savoie Johanna Harelimana Nahla Ghouali On 24 September, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced fines totalling €8 million...
9/11/2024 1:04:51 PM EU Pharmaceutical Reform: Update on the proposed changes to marketing authorisation procedures By Sally Shorthose Sophie Vo This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click...
9/5/2024 1:59:03 PM What do the Political Guidelines for the Next European Commission bring to the life sciences & healthcare industry? By Hester Borgers Ana-Maria Barbu-Nyström On 18 July 2024 President Von der Leyen laid down the path for the next European Commission in her Political Guidelines for the next...
8/27/2024 12:57:36 PM Clinical Trial Update in Ireland: New model Clinical Trial Agreement for Tripartite Clinical Trials in Ireland By Kelly Mackey Earlier this summer, the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international originator...