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European Union › New Regulations › Pharmaceutical Industry

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Hogan Lovells

EMA’S NEW WORK PLAN: Leveraging data and AI to encourage innovation and research

Hogan Lovells on

The European Medicines Agency (EMA) published a workplan on its ambition to leverage high volumes of data and artificial intelligence (AI). On 7 May 2025, the European Medicines Agency (EMA) published a joint workplan with...more

A&O Shearman

New CJEU ruling on the borderline between medicinal products and medical devices: Key takeaways

A&O Shearman on

The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...more

McDermott Will & Schulte

Key Features of the New EU Product Liability Directive: Increased Potential for Litigation in the Technology, Pharmaceutical and...

McDermott Will & Schulte on

On October 10, 2024, the Council of the European Union adopted the new EU Directive on Liability for Defective Products (New PLD), repealing Directive 85/374/EEC (PLD), adopted in 1985....more

Faegre Drinker Biddle & Reath LLP

The UK Cyber Security and Resilience Bill

Faegre Drinker Biddle & Reath LLP on

The UK government has recently announced that it plans to introduce a Cyber Security and Resilience Bill (Bill). The Bill seeks to update the 2018 Network and Information Security Regulations, which implemented the European...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

Hogan Lovells on

Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

McDermott Will & Schulte

The EU Medical Device Regulation: What’s Next?

McDermott Will & Schulte on

The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more

McDermott Will & Schulte

European SPC Manufacturing Waiver Goes into Force

McDermott Will & Schulte on

Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

Latham & Watkins LLP

Time to Prepare for New EU Medical Device Regime

Latham & Watkins LLP on

Companies should act now to prepare for the full implementation of the MDR and IVDR. On 26 May 2020, Regulation (EU) 2017/745 on medical devices (MDR) will become fully active, reflecting an overhaul of the current...more

McDermott Will & Emery

The New EU Clinical Trials Regulation Aims at Harmonization and Transparency

McDermott Will & Emery on

On June 16, 2014, Reg. (EU) No. 536/2014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes applicable, the Regulation will provide a comprehensive legal framework for...more

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