News & Analysis as of

Life Sciences European Commission European Medicines Agency (EMA)

Goodwin

European Commission Approves Moderna’s Updated COVID-19 Vaccine

Goodwin on

On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna’s COVID-19 vaccine Spikevax®.  The updated vaccine targets the LP.8.1 variant of...more

Hogan Lovells

Clinical Trials Regulation: Transition your clinical trial now

Hogan Lovells on

On 31 January 2025 the Clinical Trials Regulation will become fully applicable to all ongoing clinical trials with medicinal products in the EU. All clinical trials that have been authorized under the Clinical Trials...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Goodwin

The European Commission Proposes First Major Overhaul of the EU Medicines Regulatory Framework in 20 Years: Regulatory Data...

Goodwin on

We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more

Cooley LLP

European Commission Publishes Proposals to Revise Current EU Pharmaceutical Legislative Framework

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Yesterday, the European Commission published two legislative proposals concerning the regulation of medicinal products in the European Union. The proposals seek to consolidate existing legislation into two instruments, a...more

King & Spalding

Europe - Between The EU Clinical Trials Regulation And The UK Guideline On Clinical Trials

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Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more

Hogan Lovells

Revision of the EU general pharmaceuticals legislation – public consultation is now open

Hogan Lovells on

The EU Commission opened this afternoon the public consultation on the EU general pharmaceuticals legislation on medicines for human use. This initiative is part of the EU Pharmaceutical Strategy for Europe and calls on...more

A&O Shearman

EU Clinical Trial Regulation to Take Effect on 31 January 2022

A&O Shearman on

The European Commission has announced that the Clinical Trials Regulation, already enacted in 2014, will take effect on 31 January 2022....more

King & Spalding

Europe Update – Life Sciences Products and COVID-19: From Clinical Trials to Regulatory Flexibility

King & Spalding on

In March, most European Union (‘EU’) countries ordered some form of lockdown and adopted many national measures to address or prevent issues raised by COVID-19. The health crisis pushed national authorities to focus on their...more

Hogan Lovells

EMA publishes guidance providing regulatory adaptations for MAHs in the context of COVID-19

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On 10 April 2020, the European Commission, the EMA and the European medicines regulatory network published a notice providing guidance to stakeholders regarding regulatory expectations for medicinal products for human use...more

Jones Day

Update on Recommendations and Initiatives of EU Regulators Ahead of Brexit

Jones Day on

On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more

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