News & Analysis as of

Regulatory Agenda United Kingdom Pharmaceutical Industry

A&O Shearman

A new approach to regulation by the MHRA and NICE

A&O Shearman on

On March 17, 2025, the government published a policy paper with an Action Plan for regulation and regulators, outlining how it intends to reform the UK's regulatory system to support growth and innovation. The Action Plan...more

McDermott Will & Schulte

New Pharmaceutical Industry Standards Apply to the Promotion of Medicines in the United Kingdom: ABPI Code 2024 and the PMCPA...

McDermott Will & Schulte on

Pharmaceutical companies promoting prescription-only medicines to health professionals and other relevant decision makers in the UK must now adhere to revised industry standards that came into operation from 1 October 2024...more

Faegre Drinker Biddle & Reath LLP

The UK Cyber Security and Resilience Bill

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

Jones Day

Reversal of Burden of Proof Under Proposal for a New EU Product Liability Directive

Jones Day on

In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more

McDermott Will & Schulte

Lowest-risk Clinical Trials Will Benefit From a New Notification Scheme and a Shorter Period for Application Processing

McDermott Will & Schulte on

On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more

McDermott Will & Schulte

Great Britain and European Union Timelines: What Are the Key Dates for Transition?

The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more

Latham & Watkins LLP

European Healthcare & Life Sciences Market Update - H1 2022

Latham & Watkins LLP on

Welcome to the first edition of our European Healthcare & Life Sciences Market Update, a new report summarising key emerging trends, opportunities, and challenges facing the market in 2022. During the last 12 months, the...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 5

Hogan Lovells on

In Washington: The White House Coronavirus Task Force is warning that there may be a new fast-spreading U.S.A. variant of the coronavirus. "This fall/winter surge has been at nearly twice the rate of rise of cases as the...more

Hogan Lovells

UK post-Brexit regulation of medicines from 1 January 2021

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published a raft of guidance on how various aspects of the UK regulatory regime for medicines will operate in England, Wales and Scotland (together Great...more

Hogan Lovells

UK regulation of medical devices from 1 January 2021

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

Hogan Lovells

Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

Hogan Lovells on

On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. ...more

Hogan Lovells

New UK MHRA No Deal Guidance

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With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations....more

Hogan Lovells

Brexit snapshot: Medicines

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Do you have a centralised EU marketing authorisation holder, orphan designation holder, manufacturing activities including import, batch control or batch release sites, a Qualified Person for Pharmacovigilance (QPPV),...more

Hogan Lovells

Post-registration changes in case of no-deal Brexit

Hogan Lovells on

On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event...more

Hogan Lovells

Updated UK “no deal” Brexit guidance on medicines, medical devices and clinical trials

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2015

EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more

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