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European Union New Guidance Regulatory Oversight

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 -
Walkers

ESMA principles on third-party risk supervision

Walkers on

On 12 June 2025, ESMA published its principles on third-party risk supervision which are designed to assist supervisory authorities to identify, assess and supervise the third-party risks of EU entities operating across the...more

A&O Shearman

ESMA final guidelines on preventing and detecting market abuse under MiCAR

A&O Shearman on

The European Securities and Markets Authority (ESMA) has published its final report on the guidelines on supervisory practices for National Competent Authorities (NCAs) to prevent and detect market abuse under the Market in...more

A&O Shearman

EPC publishes Guidelines for PSPs joining payment schemes

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The European Payments Council (EPC) has issued Version 7.0 of the Adherence Guide to the EPC Payment Schemes, together with an updated webpage. The updated guide provides guidelines and template application forms for payment...more

A&O Shearman

SRB consultation on operational guidance on resolvability testing for banks

A&O Shearman on

The Single Resolution Board (SRB) has opened a consultation on its operational guidance on resolvability testing for banks under the SRB's remit. It aims to ensure that European banks are regularly testing their capabilities...more

Hogan Lovells

Draft text of new Spanish regulation on medical devices is opened for contributions

Hogan Lovells on

The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10 July 2021. The direct application of...more

Hogan Lovells

The European Commission proposes a new Pharmaceutical Strategy for the EU

Hogan Lovells on

On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more

Orrick - Antitrust Watch

The Implications Of Brexit On The Competition Law Landscape: Key Takeaways From The CMA’s ‘Guidance On The Functions Of The CMA...

The UK will no longer be a Member State of the European Union (the “EU”) as of 11 p.m. on 31 January 2020 (“Exit Day”). A ‘transition period’ will run from Exit Day until 11 p.m. on 31 December 2020 (the “Transition Period”)....more

Mintz - Privacy & Cybersecurity Viewpoints

Revised Guidelines on the Territorial Scope of the GDPR and Local Representatives

The European Data Protection Board (EDPB) recently published an updated version of its guidelines on the territorial scope of the GDPR, which were initially issued just over a year ago. The revised Guidelines do not...more

Hogan Lovells

New French Guidelines on Cookies and Trackers

Hogan Lovells on

On 19 July the French Data Protection Authority (the “CNIL”) published new guidelines on cookies and trackers. These replace the existing Recommendation No. 2013-378 of 5 December 2013, are intended to be in line with...more

Hogan Lovells

European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem

Hogan Lovells on

The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities...more

Hogan Lovells

European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent...

Hogan Lovells on

Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more

Polsinelli

New Guidelines on GDPR’s Territorial Scope

Polsinelli on

The European Data Protection Board (“EDPB”) recently released Guidelines 3/2018 on the territorial scope of the GDPR (Article 3). ...more

Hogan Lovells

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

Hogan Lovells on

On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more

Hogan Lovells

The EMA has adopted new guidelines on good pharmacovigilance practices in paediatric populations

Hogan Lovells on

The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations Chapter (IV) regarding specific considerations for the paediatric...more

Hogan Lovells

New “rolling plan” and new guidance documents in relation to the MDR and IVDR

Hogan Lovells on

The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively....more

Hogan Lovells

UK Government Publishes Guidance for Life Sciences Companies on Brexit Transition

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The UK Government has published guidance for life sciences companies on the Brexit implementation period, which is intended to take effect from 30 March 2019 to the end of 2020. ...more

Latham & Watkins LLP

China Revises Hazardous Substances Restriction Laws

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China’s Ministry of Industry and Information Technology (MIIT) has recently announced a revised version of the Restriction of Hazardous Substances (RoHS 1), which will come into effect on July 1, 2016. The revised...more

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