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European Commission Clinical Trials European Medicines Agency (EMA)

Goodwin

The European Parliament Adopts Position on the European Commission’s Proposal for the First Major Overhaul of the EU Medicines...

Goodwin on

In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...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

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

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

EU Guidance to sponsors, investigators on how to manage clinical trials during the COVID-19 pandemic

Hogan Lovells on

In addition to guidance issued by European Union (EU) Member States on the conduct of clinical trials during the COVID-19 pandemic, harmonized EU guidance has now been issued. On Friday, March 20, the European Commission, the...more

Goodwin

Biosimilars Update: Bio-Thera Solutions BAT1706 (bevacizumab) and Pfizer RUXIENCE (rituximab)

Goodwin on

Below are a few biosimilar-related updates from the past week. Bio-Thera Solutions announced that in a Phase III clinical trial of BAT1706 (bevacizumab), BAT1706 met its primary endpoint, demonstrating “equivalence in...more

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