News & Analysis as of

Regulatory Standards Regulatory Oversight European Union

A&O Shearman

ESMA consultation on transparency and integrity of ESG rating activities

A&O Shearman on

The European Securities and Markets Authority (ESMA) has published a consultation paper on draft regulatory technical standards (RTS) on the transparency and integrity of environmental, social and governance (ESG) rating...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

Skadden, Arps, Slate, Meagher & Flom LLP

The Standard Formula: Encyclopaedia of Prudential Solvency – Chapter 1: The IAIS and the ICS

Established in 1994, the International Association of Insurance Supervisors (IAIS) is a voluntary membership organisation comprising insurance regulatory authorities, central banks, ministries of finance, and other...more

A&O Shearman

European Commission Adopts Regulatory Technical Standards on Conduct of Oversight Activities under EU Digital Operational...

A&O Shearman on

The European Commission has adopted a Commission Delegated Regulation supplementing the EU Digital Operational Resilience Act with regard to Regulatory Technical Standards on harmonization of conditions enabling the conduct...more

A&O Shearman

European Central Bank Publishes Paper on TIBER-EU and EU Digital Operational Resilience Act Requirements

A&O Shearman on

The European Central Bank has published a paper outlining how the European framework for threat intelligence-based ethical red teaming, the TIBER-EU framework, can help competent authorities and financial entities fulfil...more

Baker Donelson

Analyzing the EU Artificial Intelligence Act: Spotlight on Biometrics

Baker Donelson on

The European Parliament formally adopted the EU Artificial Intelligence Act (AI Act), a first-of-its-kind comprehensive regulation governing the use of artificial intelligence (AI), on March 13, 2024. While applicable to a...more

Goodwin

Acquiring or Investing in EU Crypto-Asset Businesses: Further Clarity on MiCA

Goodwin on

In our previous alert “Acquiring or Investing in EU Crypto-Asset Businesses: MiCA’s Impact,” we discussed the impact of the European Union (EU) Markets in Crypto-Assets Regulation (MiCA) on the acquisition or investment in EU...more

Baker Donelson

To Boldly Go Places: EU's AI Act is Set to Become the Real Deal

Baker Donelson on

On December 8, 2023, EU policymakers reached an agreement on the Artificial Intelligence Act (AI Act). As a standard-bearer for global digital and data governance, the EU has been setting regulatory benchmarks on emerging...more

Hogan Lovells

New Medical Devices Regulation in Spain

Hogan Lovells on

On 23 March 2023 the new Spanish Medical Devices Regulation (Spanish MDR) came into force. After a lengthy wait, the medical devices industry (and any other interested sector) finally has access to the final text and knows...more

Hogan Lovells

Can sterile drug manufacturers implement EU GMP Annex 1 requirements before August?

Hogan Lovells on

In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...more

Goodwin

Buying a UK Crypto Business: The New Regulatory Hurdles

Goodwin on

​​​​​​​The advance of the regulation of crypto-assets and crypto-related service providers has been piecemeal in the U.K. The latest round of changes took place in the Money Laundering Regulations 2017 (MLR) on 1 September...more

Hogan Lovells

Key legal concerns for advanced therapy medicinal product (ATMP) sponsors in Europe

Hogan Lovells on

In recent years we have seen more and more gene and cell therapies coming successfully to market – but many more such candidates have not made it to market, or been unable to obtain sufficient reimbursement. Gene and cell...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

Hogan Lovells

European Commission announced its plan to postpone the implementation of the MDR by one year

Hogan Lovells on

The European Commission today announced that it is preparing a proposal to postpone the entry into application of the new Medical Devices Regulation (MDR). The proposed postponement would be for one year....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

Hogan Lovells

Gearing up for enhanced consumer protection: the impact of the EU's new rules

Hogan Lovells on

On 7 January 2020, Directive (EU) 2019/2161 (the "Directive") came into force, setting into motion a swathe of measures aimed at modernizing the existing consumer protection rules, bolstering the level of protection available...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l December 2019

LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Warning Letters, Consumer Update On CBD, Sparking Litigation Against CBD Cos. - The U.S. Food and Drug Administration (FDA) has issued a consumer update on cannabidiol...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l November 2019 #2

LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more

Hogan Lovells

A Turning Point for Tech – Global survey on digital regulation

Hogan Lovells on

Whilst political uncertainty may have businesses’ attention fixed, the Hogan Lovells Global Survey on Digital Regulation: ‘A Turning Point for Tech’ suggests that tech companies should be looking elsewhere. During yesterday’s...more

Hogan Lovells

New MDCG Guidance on Summary of Safety and Clinical Performance under the Medical Devices Regulation (MDR)

Hogan Lovells on

On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers...more

Cadwalader, Wickersham & Taft LLP

European Banking Authority Publishes Question and Answer Relating to Originator Risk Retention Holders in Securitisations

On 13 September 2019, the European Banking Authority (the “EBA”) updated its guidance in respect of the Securitisation Regulation[1] by publishing an answer to a question submitted to it in November 2018 by the Association...more

Hogan Lovells

Publication of rules on designation of expert panels under the Medical Devices Regulations

Hogan Lovells on

In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision)...more

Hogan Lovells

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open!

Hogan Lovells on

On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more

Hogan Lovells

European Product Liability Directive: Stay tuned, guidance is around the corner

Hogan Lovells on

It's been a year since the European Commission published its Fifth Report on the application of the European Product Liability Directive (the "Directive") and set up expert panels to develop its thinking on next policy steps....more

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