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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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Practice notes
The experimental use and Bolar-type exemptions to patent infringementPatent systems are intended to foster innovation, not to impede it. For this...
2nd Jun
In-house
News
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...
3rd Jun
Precedents
Clinical Research Organisation (CRO) master services agreementDATA PROTECTION NOTICE: Please note that the drafting of clause 7 (Data Protection), in...
30th May
Practice notes
The EU Clinical Trials RegulationThis Practice Note looks at Regulation (EU) 536/2014, the EU Clinical Trials Regulation (CTR), which governs clinical...
Produced in partnership with Eveline Van Keymeulen of Latham & Watkins and Jeanne Fabre of Latham & Watkins
30th May
Precedents
Medical devices due diligence questionnaireIntroductionThis medical devices regulatory due diligence questionnaire relates to the proposed purchase by...
30th May
Flowcharts
Lifecycle of a medical device—flowchartThis Flowchart illustrates the typical lifecycle of a medical device. The lifecycle identifies eight key stages...
2nd Jun
Practice notes
Biotechnology patentsPatenting biotechnological inventionsBiotechnological inventions are, in principle, patentable. While there is no general...
30th May
Practice notes
Unlicensed medicinal products and off-label use of medicinal productsThis Practice Note explores unlicensed medicinal products and the various ways...
Produced in partnership with Dr Peter Feldschreiber of 4 New Square
30th May
News
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the implementation of changes to pharmacovigilance for...
3rd Jun
Practice notes
The regulation of medical devices in the UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...
30th May
News
The National Archives has published the judgment in British Standards Institution v RRR Manufacturing Pty Ltd, R (on the application of) [2024] EWCA...
3rd Jun
News
The Competition and Markets Authority (CMA) has announced a Phase 1 merger inquiry into Roche Diagnostics Ltd's acquisition of point-of-care testing...
3rd Jun
News
The Department for Science, Innovation and Technology (DSIT) has released the interim International Scientific Report on the Safety of Advanced...
3rd Jun
Practice notes
The regulation of advanced therapy medicinal productsThe development of medicine, biomicrobiology and biotechnology has led to the emergence of a...
Produced in partnership with Alexander Roussanov of Arnold & Porter and Heba Jalil of Arnold & Porter
30th May
Practice notes
Intellectual property protection for digital healthThis Practice Note discusses the various intellectual property (IP) rights that can be used to...
Produced in partnership with Dr. Fiona Kellas of Maucher Jenkins
2nd Jun
Most recent Pharmaceutical regulation content
Practice notes
The Windsor Framework—trade between Northern Ireland, the UK and EUIntroductionOn 27 February 2023 UK Prime Minster Rishi Sunak and EU Commission...
27th Jun
Practice notes
BiosimilarsThis Practice Note explains what a similar biological medicinal product or biosimilar is. It sets out the UK and EU regulatory framework...
Produced in partnership with Eleanor Denny, associate, and Claire Phipps-Jones, senior associate, of Bristows LLP
24th Jun
Practice notes
Artificial intelligence—UK regulation and the National AI StrategyThis Practice Note sets out the UK approach to regulating artificial intelligence...
23rd Jun
Practice notes
Post-Brexit transition period—the regulation of medicinal productsThis Practice Note deals with key issues that affect marketing authorisations (MAs)...
18th Jun
Practice notes
Orphan medicinal productsOrphan medicinal products (OMPs) are medicines used to prevent, diagnose or treat rare medical conditions and diseases. Given...
Produced in partnership with Sarah Faircliffe of Bird & Bird
18th Jun
Practice notes
Medicines and Medical Devices Act 2021This Practice Note provides an overview of the Medicines and Medical Devices Act 2021 (MMDA 2021) which, in...
18th Jun
Practice notes
Personalised medicine—introduction to the technologyWhat is personalised medicinePersonalised medicine has existed for quite some time. Physicians...
Produced in partnership with Daniel Bouthillier, Ma’n H. Zawati and Yann Joly
16th Jun
Practice notes
Introduction to borderline productsThis Practice Note provides an introduction to the concept of borderline products, how the regulatory status of...
16th Jun
Practice notes
Life sciences divergence tracker 2021–2023 [Archived]ARCHIVED: This Practice Note has been archived and is not maintained.This Practice Note served as...
12th Jun
Flowcharts
Lifecycle of a pharmaceutical product—flowchartThis flowchart illustrates the typical lifecycle of a medicinal product. This lifecycle can be broken...
12th Jun
Practice notes
Marketing authorisations in the EU—content and form of the application and other practical considerationsAs explained in Practice Note: Marketing...
12th Jun
Practice notes
Coronavirus (COVID-19)—regulatory implications for the UK and European life sciences industry [Archived]ARCHIVED: This Practice Note has been archived...
Produced in partnership with Maria Isabel Manley of Sidley Austin, Zina Chatzidimitriadou of Sidley Austin and Sidley Austin
12th Jun
Practice notes
Regulation of CBD and medicinal cannabis productsSTOP PRESS—Impact of the Retained EU Law (Revocation and Reform) Act 2023: This document contains...
12th Jun
Practice notes
The regulation of advanced therapy medicinal productsThe development of medicine, biomicrobiology and biotechnology has led to the emergence of a...
Produced in partnership with Alexander Roussanov of Arnold & Porter and Heba Jalil of Arnold & Porter
12th Jun
Practice notes
Manufacturing of medicinal products for human useManufacturers of medicinal products must comply with certain minimum standards in their production...
12th Jun
Practice notes
EU variations to marketing authorisations of medicinal productsA medicinal product may only be supplied and used within the EU in accordance with its...
12th Jun
Practice notes
Marketing authorisations in the EU—regulatory procedures for approval of medicinal productsNo medicinal product may be placed on the market without...
12th Jun
Practice notes
UK marketing authorisations for medicinal productsThis Practice Note summarises the law relating to marketing authorisation (MAs) for medicinal...
12th Jun
Practice notes
An introduction to the regulation of medicinal productsEU and UK legal framework governing medicinal productsA complex array of requirements and...
12th Jun
Flowcharts
EU centralised marketing authorisation procedure—flowchartNo medicinal product may be placed on the market unless it has been approved. This Flowchart...
12th Jun
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