Germany has taken another step to improve the conditions for pharmaceutical research & development in Germany. Now, the Federal Government has adopted the “Standard Contractual Clauses” for pharmaceutical clinical trial agreements. In this blog, we discuss what the new standard clauses cover and how they will affect clinical trials in
Continue Reading Germany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon
MHRA Issues Statement of Policy Intent Regarding Early Access to Innovative Medical Devices
On 31 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) issued a statement of policy intent relating to a service to provide early access to the Great Britain market for innovative medical devices (“Early Access Service”). Although this statement is non-binding, it indicates further efforts by the MHRA to reduce unwarranted barriers to market entry, through faster, risk-proportionate, and predictable routes to regulatory approval – in line with Action 25 of the Life Sciences Sector Plan (published on 16 July 2025).Continue Reading MHRA Issues Statement of Policy Intent Regarding Early Access to Innovative Medical Devices
MHRA Announces Consultation Response on Reforms to GB Pre-Market Medical Device Regulation
On 22 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published the outcome of its most recent medical device-related consultation. The MHRA also announced its intention to consult further on the indefinite recognition of CE-marked medical devices in Great Britain, with this consultation expected to take place later in 2025.Continue Reading MHRA Announces Consultation Response on Reforms to GB Pre-Market Medical Device Regulation
What Companies Should Know About the WHO Pandemic Agreement
Image Credit: World Health Organization
On 16 April 2025, Member States of the World Health Organization (WHO) concluded negotiations on a new international treaty: the Agreement on pandemic prevention, preparedness and response (“WHO Pandemic Agreement”). Set to be adopted at the May 2025 World Health Assembly, this landmark accord aims
Continue Reading What Companies Should Know About the WHO Pandemic Agreement
EU Joint Procurement – An Overview
The joint procurement by the European Commission (“Commission”) and the Member States of COVID-19 vaccines and therapeutics presented a significant milestone in the EU’s management of the pandemic. In the aftermath of the pandemic, there have been repeated calls for more joint procurement. This blog explores the existing mechanisms for joint procurement and also considers the Commission’s proposal for a Critical Medicines Act (“CMA”) and what it would mean for public procurement.
At a high level, there are already various mechanisms for joint procurement of medicinal products and medical devices both with and without involvement of the Commission. The CMA proposal does not fundamentally change that but rather supplements the existing regimes.
The key aspect to be aware of is that both the existing regime and the draft CMA merely establish a framework for joint procurement, including the relationship among Member States and the Commission (if involved). This framework focusses on establishing when joint procurement is possible and the mechanism for getting a joint procurement set up. However, the framework does not specify in what circumstances Member States and/or the Commission might choose to engage in joint procurement, the terms of the tender or any resulting contract.Continue Reading EU Joint Procurement – An Overview
The Covington European Life Sciences Symposium 2025
On 23 January 2025, we hosted the 2025 edition of the Covington European Life Sciences Symposium. The Symposium brought together colleagues from London, Brussels, Frankfurt and Dublin with our industry connections to explore the evolving challenges and opportunities facing the European life sciences sector.Continue Reading The Covington European Life Sciences Symposium 2025
European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers
On 15 January 2025, the European Commission published an action plan on the cybersecurity of hospitals and healthcare providers (the “Action Plan”). The Action Plan sets out a series of EU-level actions that are intended to better protect the healthcare sector from cyber threats. The publication of the Action Plan follows a number of high-profile incidents in recent years where healthcare providers across the European Union have been the target of cyber attacks.Continue Reading European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers
European Commission Consults on Update to Pharmacovigilance Rules
On 18 December 2024, the European Commission published a proposed implementing regulation relating to pharmacovigilance (“PV”) requirements for human medicines marketed in the EU (“Proposal”), which will update European Commission Implementing Regulation (EU) 520/2012 (“Implementing Regulation”). While the core PV requirements, including the obligation to establish and operate a PV system and the key reporting requirements, are set out in Regulation (EC) No 726/2004 and Directive 2001/83/EC, the Implementing Regulation provides detailed requirements on the performance of PV activities, including the need for a PV system master file (“PSMF”), more comprehensive requirements for the PV quality system, and detailed provisions relating to periodic safety update reports (“PSURs”).
The proposed changes aim to harmonize the performance of PV activities by marketing authorization holders (“MAHs”), national competent authorities and the European Medicines Agency (“EMA”), and in some cases widen the scope of the Implementing Regulation’s PV requirements. Other changes are clarificatory in nature.Continue Reading European Commission Consults on Update to Pharmacovigilance Rules
Just Weeks After COP16: CBD Secretariat Launches Stakeholder Consultations for the Operationalization of the DSI Mechanism. How Should Companies Engage?
The Secretariat of the Convention on Biological Diversity (CBD) has opened four consultations inviting stakeholder input on the development of the new Multilateral Mechanism on Benefit-Sharing (MLM) for Digital Sequence Information (DSI), including the establishment of the global benefit-sharing fund known as “The Cali Fund.”
Companies are encouraged to
Continue Reading Just Weeks After COP16: CBD Secretariat Launches Stakeholder Consultations for the Operationalization of the DSI Mechanism. How Should Companies Engage?
Are you Windsor Framework ready? A focus on pharmaceutical supply chains and promotional material
In recent weeks, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published further guidance relating to the implementation of the Windsor Framework. From 1 January 2025, changes due to the Windsor Framework for the licensing, labelling and wholesale dealing of human medicinal products in the UK will become effective. The new measures require, amongst other things: (i) all human medicinal products intended for the UK market to be authorized by the MHRA; (ii) a single UK-wide pack that bears a “UK only” label; and (iii) disapplication of the EU Falsified Medicines Directive 2011/62/EU (“EU FMD”) requirements to UK-wide packs.
Following the MHRA’s initial publication of guidance focusing on the changes to labelling and packaging (please see our blog post here), the Agency has now issued guidance relating to wholesalers and manufacturers (“Wholesaler and Manufacturer Guidance), licensing (“Licensing Guidance”) and advertising (“Advertising Guidance”).
We explore some of the key requirements and recommendations for supply chains and promotional material arising from this new guidance below.Continue Reading Are you Windsor Framework ready? A focus on pharmaceutical supply chains and promotional material