This is one in a series of Inside EU Life Sciences blogs on the European Commission’s (“Commission’s”) latest proposal for a European Biotech Act.
On 16 December 2025, the Commission announced a proposal to introduce a new draft Regulation (“Proposed Regulation”) aimed at boosting the EU’s competitiveness in the biotech
Continue Reading European Biotech Act: Potential new extension for supplementary protection certificates (SPCs) for ATMPs and biotechnology medicines
This is one in a series of Inside European Life Sciences blogs on the proposal for an EU Biotech Act in the form of a regulation that the European Commission released on 16 December 2025. This blog focuses on the proposals to amend the EU’s clinical trial rules and establish
Continue Reading The Proposed EU Biotech Act Aims to Accelerate and Streamline Procedures for the Approval of Clinical Trials and Combined Studies
The European Commission announced today (16 December) its plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices (“IVDs”). Many industry stakeholders have criticized the current EU device rules as being slow, costly, unpredictable, and unnecessarily complex. Under the proposed revisions, the Commission
Continue Reading European Commission Announces (Long Awaited) Proposal to Simplify EU Medical Device Regulations
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
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
In a precedent decision, on 13 November 2024, the EU General Court annulled significant parts of a Commission Regulation, which sought to restrict or place under scrutiny the addition of certain botanicals containing hydroxyanthracene derivatives (“HADs”) to foods. The Court held that the Commission had exceeded its powers by seeking to regulate botanical “preparations.” Moreover, the Commission, in relying on the scientific opinion of the European Food Safety Authority (“EFSA”), had failed to demonstrate that the relevant substances would be ingested in amounts greatly exceeding those consumed from a normal diet or otherwise represented a potential risk to consumers. Continue Reading EU Court Overturns EU-wide Botanical Food Ban
On 10 April 2024, the European Parliament adopted its position on the Commission proposal to reform the core EU pharmaceutical legislation (see here and here). In doing so, the European Parliament has met its ambitious timeline to adopt its position before the upcoming Parliamentary elections and marks a significant step in the legislative process.
Parliament’s position comes less than a year since the Commission published its proposal, which consists of a new directive replacing Directive 2001/83/EC and a new master regulation replacing Regulation 726/2004, which will also consolidate the orphan and pediatric medicines regulations (see our prior EU Pharma Legislation Review blog series). Many of Parliament’s amendments to the Commission proposal will be seen as improvements by the innovative industry, but there remain challenges and unresolved questions.
We provide below the top 8 takeaways for industry to consider during the next phase of the legislative process, which is a detailed review by the Council.Continue Reading European Parliament adopts its Position on EU Pharma Law Review: 8 Key Takeaways for Industry
The European Parliament and Council are currently negotiating the wording of a new Regulation establishing a Single Market emergency instrument (“SMEI”). This new measure builds on the experience gained from the COVID-19 crisis and gives new powers to the Commission, in close cooperation with the Member States. This blog briefly
Continue Reading Single Market Emergency Instrument: Potential Impact on Medical Devices
Following the COVID-19 pandemic and the relatively slow approval of vaccines in the EU versus other key jurisdictions, as part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023, the European Commission has proposed to introduce temporary emergency marketing authorizations (“TEMAs”) for use when there
Continue Reading EU Pharma Legislation Review Series: Temporary Emergency Marketing Authorizations
The European Commission (the “Commission”) wants to “avoid unnecessary administrative and financial burdens for applicants and competent authorities.” As such, the Commission’s proposal for a revised Directive on the Union Code Relating to Medicinal Products for Human Use (the “Directive”) retains the Decentralized Procedure (“DCP”) and Mutual Recognition
Continue Reading EU Pharma Legislation Review Series: National MA Procedures Including the Mutual Recognition Procedure and Decentralized Procedure