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European Union › Regulatory Oversight › Regulatory Agencies

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 -
A&O Shearman

Regulatory monitoring - June 2025

A&O Shearman on

The EBA published a keynote speech delivered by its Chairperson, José Manuel Campa, at a high-level meeting for European supervisors in Ljubljana, Slovenia, on the importance of an efficient and effective financial services...more

Bergeson & Campbell, P.C.

NIA Issues Position Paper on Divergent EU Approaches to Nano and Advanced Materials

Bergeson & Campbell, P.C. on

On June 11, 2025, the Nanotechnology Industries Association (NIA) published a position paper entitled Bridging the Governance Gap: Divergent EU Approaches to Nano and Advanced Materials that highlights industry challenges...more

A&O Shearman

RTS on criteria for the composition of joint examination teams under EU DORA published in OJ

A&O Shearman on

Commission Delegated Regulation 2025/420 has been published in the Official Journal of the EU. This Delegated Regulation supplements Regulation 2022/2554 on digital operational resilience for the financial sector (DORA)...more

Barnea Jaffa Lande & Co.

The Future Is Already Here

Barnea Jaffa Lande & Co. on

Since the internet became ubiquitous during the 1990s, only a handful of technologies have been developed that are so far-reaching they put ethical and legal questions to the test. Among these select few is artificial...more

Goodwin

European Biosimilar Regulatory Updates

Goodwin on

STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in UK - On January 16, 2023, STADA Arzneimittel AG (STADA) and Xbrane Biopharyma AB (Xbrane) announced that the UK’s Medicines and Healthcare product Regulatory...more

Goodwin

Emer Cooke takes office as first woman head of EMA

Goodwin on

Emer Cooke, with 30 years’ experience in international regulatory affairs, took up her position this morning as Executive Director of EMA with a renewable five-year mandate. Previously, Ms. Cooke worked for the pharmaceutical...more

BCLP

Highly impactful - UK National Security & Investment Bill introduces mandatory Government review of a wide range of transactions

BCLP on

On 11 November, the UK Government introduced to Parliament the long-awaited National Security and Investment Bill. The Bill, which is expected to be enacted in Spring 2021, is a transformative event for investors in UK...more

Hogan Lovells

UK MHRA consults on no-deal Brexit legislation

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more

Womble Bond Dickinson

Higher than expected European Medicines Agency staff losses will impact its business continuity plan

Womble Bond Dickinson on

The EMA will be launching Phase 3 of its business continuity plan on October 1, 2018 at the latest, however, the detail of the plan will now be impacted by the EMA announced this week that it has realized that it will lose...more

Hogan Lovells

UK publishes paper on Brexit and medicines regulation

Hogan Lovells on

On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more

Hogan Lovells

EMAmsterdam: Hogan Lovells welcomes its new neighbour

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By Hein van den Bos, Ruth Franken and Silvia Gardini After months of discussion, a final vote has been cast on the European Medicines Agency (EMA)'s new home post-Brexit. And it's right around the corner from us, here in...more

Hogan Lovells

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

Hogan Lovells on

Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more

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