Pharmaceutical regulation

Stay ahead in the ever-evolving landscape of pharmaceutical regulation with our expert guidance. From compliance with stringent UK and EU directives to navigating global market entry requirements, we provide the essential tools and insights legal professionals need to advise clients confidently.
We delve into the critical aspects of drug approval processes, marketing authorisations, and post-market surveillance, ensuring you stay informed on the latest regulatory updates and best practices. Equip yourself with the knowledge to tackle regulatory challenges head-on and deliver exceptional legal advice within the life sciences sector.

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Advanced therapeutics Advertising of medicines Borderline products Commercialisation Manufacture, marketing and sale Medical devices Pharmaceuticals—regulatory framework

Latest Life Sciences News

Life Sciences weekly highlights—28 August 2025

Life Sciences weekly highlights—28 August 2025

The following Life Sciences news provides comprehensive and up to date legal information on Life Sciences weekly highlights—28 August 2025

MHRA issues statement of policy intent regarding early access to innovative medical devices

MHRA issues statement of policy intent regarding early access to innovative medical devices

The following Life Sciences news provides comprehensive and up to date legal information on MHRA issues statement of policy intent regarding early access to innovative medical devices

MHRA guidance for pilot streamlining assessment of Route B substantial modifications to clinical trial approvals

MHRA guidance for pilot streamlining assessment of Route B substantial modifications to clinical trial approvals

Swissmedic launches medical device registration module for national database

Featured Life Sciences content

Introduction to technology transfer agreements in the Life Sciences industry

Introduction to technology transfer agreements in the Life Sciences industry

Introduction to technology transfer agreements in the Life Sciences industryWhat is a technology transfer agreement?The term ‘technology transfer...

Regulation of cosmetic products in the UK

Regulation of cosmetic products in the UK

Regulation of cosmetic products in the UKThis Practice Note provides an overview of the UK regulatory framework for cosmetics. It sets out the legal...

Intellectual property protection for medical devices

Intellectual property protection for medical devices

Intellectual property protection for medical devicesChanges to intellectual property (IP) law from 1 January 2021Before discussing how intellectual...

Second and subsequent medical use patent claims

Second and subsequent medical use patent claims

Second and subsequent medical use patent claimsBackground to medical use claimsSecond (and subsequent) medical use patent claims are specific to the...

Practice notes

The experimental use and Bolar-type exemptions to patent infringement

The experimental use and Bolar-type exemptions to patent infringementPatent systems are intended to foster innovation, not to impede it. For this...
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Produced in partnership with Charlie French of Bristows and Milly Wickson of Bristows
2nd Jun
tag iconIn-house
News

The 2024 ABPI Code of Practice—what are the key proposed changes?

The PMCPA has recently launched a consultation to update:•the 2021 ABPI Code of Practice•the Constitution and Procedure which sets out how the PMCPA...
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3rd Jun
Precedents

Clinical Research Organisation (CRO) master services agreement

Clinical Research Organisation (CRO) master services agreementDATA PROTECTION NOTICE: Please note that the drafting of clause 7 (Data Protection), in...
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30th May
Practice notes

The EU Clinical Trials Regulation

The EU Clinical Trials RegulationThis Practice Note looks at Regulation (EU) 536/2014, the EU Clinical Trials Regulation (CTR), which governs clinical...
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Produced in partnership with Eveline Van Keymeulen of Latham & Watkins and Jeanne Fabre of Latham & Watkins
30th May
Precedents

Medical devices due diligence questionnaire

Medical devices due diligence questionnaireIntroductionThis medical devices regulatory due diligence questionnaire relates to the proposed purchase by...
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30th May
Flowcharts

Lifecycle of a medical device—flowchart

Lifecycle of a medical device—flowchartThis Flowchart illustrates the typical lifecycle of a medical device. The lifecycle identifies eight key stages...
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2nd Jun
Practice notes

Biotechnology patents

Biotechnology patentsPatenting biotechnological inventionsBiotechnological inventions are, in principle, patentable. While there is no general...
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Produced in partnership with Nicole Jadeja of Pinsent Masons and Christopher Leung of Fieldfisher
30th May
Practice notes

Unlicensed medicinal products and off-label use of medicinal products

Unlicensed medicinal products and off-label use of medicinal productsThis Practice Note explores unlicensed medicinal products and the various ways...
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Produced in partnership with Dr Peter Feldschreiber of 4 New Square
30th May
News

MHRA releases guidance on pharmacovigilance following Windsor Framework agreement

The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the implementation of changes to pharmacovigilance for...
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3rd Jun
Practice notes

The regulation of medical devices in the UK

The regulation of medical devices in the UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...
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30th May
tag iconBrexit
News

Court of Appeal allows appeal in British Standards v RRR Manufacturing

The National Archives has published the judgment in British Standards Institution v RRR Manufacturing Pty Ltd, R (on the application of) [2024] EWCA...
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3rd Jun
News

CMA announces Phase 1 merger inquiry into Roche Diagnostics

The Competition and Markets Authority (CMA) has announced a Phase 1 merger inquiry into Roche Diagnostics Ltd's acquisition of point-of-care testing...
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3rd Jun
News

DSIT publishes international scientific report on advanced AI safety

The Department for Science, Innovation and Technology (DSIT) has released the interim International Scientific Report on the Safety of Advanced...
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3rd Jun
Practice notes

The regulation of advanced therapy medicinal products

The regulation of advanced therapy medicinal productsThe development of medicine, biomicrobiology and biotechnology has led to the emergence of a...
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Produced in partnership with Alexander Roussanov of Arnold & Porter and Heba Jalil of Arnold & Porter
30th May
Practice notes

Intellectual property protection for digital health

Intellectual property protection for digital healthThis Practice Note discusses the various intellectual property (IP) rights that can be used to...
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Produced in partnership with Dr. Fiona Kellas of Maucher Jenkins
2nd Jun
News

Competition Appeal Tribunal upholds £130m in Allergan fines

...
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2nd Jun

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Template for regulatory references given by SMCR firms and disclosure requirements

Template for regulatory references given by SMCR firms and disclosure requirements[Insert addressee details]Dear [insert name][It is our understanding that [insert name of prospective employee] [was an employee of yours between the dates of [insert dates as appropriate] OR is a current employee of