News & Analysis as of

Regulatory Agenda United Kingdom Prescription Drugs

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

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

Hogan Lovells

New UK MHRA No Deal Guidance

Hogan Lovells on

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

Hogan Lovells on

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

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

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