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In Healthcare Services

The Tide is Turning for Psychedelics-based Therapies in the UK

by , and 6 Mins Read

Last month, the UK House of Commons debated the current state of regulatory and legal hurdles negatively affecting the development of psilocybin-based (the psychedelic compound most commonly found in ‘magic mushrooms’) therapies for mental and physical health disorders in the UK. The debate resulted from an e-petition, which garnered 11,824 votes in February this year. The debate saw a consensus among Members of Parliament across party lines, collectively supporting the proposal for rescheduling psilocybin from…

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In Digital Health

Top 10 tips: Procuring AI Solutions and GDPR compliance for Pharma & MedTech

by 7 Mins Read

We’ve set out our top ten tips on ensuring GDPR compliance if your organisation is procuring AI solutions from third parties, whether this is to train an AI imaging system, integrate AI solutions into a patient-facing app or to allow your staff to make use of generative AI. These tips are based on the issues which we see are attracting regulatory scrutiny in practice, the potential stumbling blocks we’re coming across in supplier terms, as…

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In Medical Devices

Welcome Clarity as UK’s MHRA Extends its Acceptance of EU CE Marking

by , and 3 Mins Read

On 27 April 2023, the MHRA announced that the UK government intends to introduce legislation this spring that will extend the acceptance period of CE marked devices onto the Great Britain market. The MHRA’s announcement has provided much needed. This statement made by the MHRA is an update to their announcement made on 28 March 2023, on which we previously blogged. This is a very welcome step from the MHRA after what has been a…

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In Medical Devices

The Clocks Are No Longer Ticking; EU (and UK’s MHRA) Give Manufacturers More Time to Certify Medical Devices and MHRA buys time with MORE

by , and 3 Mins Read

On 15 March 2023 (Regulation (EU) 2023/607), the EU extended both the transition period for the EU Medical Device Regulations (EU MDR) and the validity of CE mark certificates. The new arrangements give manufacturers more time than previously anticipated to get their medical devices certified and they recognise the capacity challenges faced by notified bodies. Higher-risk devices now have until 31 December 2027 to ensure that they comply with EU MDR requirements and medium to…

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In Digital Health

UK vs EU Approach to Regulating AI: From One Extreme to Another?

by 5 Mins Read

In its white paper published last month, the UK Government set out its principles-based, adaptive approach to regulating AI. The UK approach stands in stark contrast to the more static and prescriptive approach of the EU AI Act. Instead of assigning responsibility for AI governance to a new single regulator, the UK Government is empowering existing regulators to come up with tailored approaches for specific sectors. The aim is to ensure that the UK remains a flexible…

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In Healthcare Services

UK Treasury Consults on the Design of a Single R&D Tax Relief Scheme

by 3 Mins Read

HM Treasury (HMT) has launched a consultation seeking views on the design of a single, simplified research and development (R&D) tax relief scheme, merging the existing R&D expenditure credit (RDEC) and the small and medium enterprise (SME) R&D relief into an RDEC-like scheme. The new scheme, if implemented, would apply in respect of expenditure incurred from 1 April 2024. The integration of the existing schemes with a single approach may have a decisive impact on the future…

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In Pharmaceuticals & Biotech

Long-Awaited New Social Media Guidance From UK’s PMCPA

by , and 2 Mins Read

In brief The first ever guidance on social media has been issued by the Prescription Medicines Code of Practice Authority (PMCPA) to help pharmaceutical companies apply the high standards demanded by the industry’s ABPI Code of Practice to all their online communications channels. The PMCPA Social Media Guidance 2023 has been produced in consultation with the Medicines and Healthcare Products Regulatory Agency (MHRA), the ABPI, and pharmaceutical companies. It includes advice for companies to help them use…

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In Pharmaceuticals & Biotech

UKs MHRA announces extension of the European Commission Decision Reliance Procedure (ECDRP)

by , and 2 Mins Read

In brief The MHRA lifted some extra burden from the industry by extending the European Commission Decision Reliance Procedure (ECDRP) by 12 months until 31 December 2023. The ECDRP was introduced following Brexit and is available to medicines approved via the EU centralized procedure. Before 31 December 2023, in situations where a Committee for Medicinal Products for Human Use (CHMP) positive opinion has been received, applicants can continue to submit their ECDRP Marketing Authorisation Application (MAA) or…

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In Health Data Privacy & Security

3 Steps to Access Health Data for Research in the UK

by 3 Mins Read

In brief The UK’s Health Research Authority (HRA) has unveiled new guidance that signposts the three essential steps to access health and care data for research purposes. The guidance delves into a point that researchers often miss: the common law duty of confidentiality runs in parallel to data privacy laws, and each regime needs to be considered separately to ensure data access requests can stand up to regulatory scrutiny. Step 1: Scoping — what are the data…

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