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Julia Gillert

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In EU Pharmaceutical Package

EU Pharma Package: How Significant are the Proposals for Orphan Medicines?

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On 26 April 2023 the European Commission published its Proposals to Reform the EU pharmaceutical legislation.[1] We continue our analysis of the Proposals with this focus upon the changes concerning orphan medicines. 1.The current Orphan Regulation (EC) No 141/2000 will be repealed, and the new orphan provisions will be integrated into the general Regulation laying down the EU procedures for the authorisation and supervision of medicines. 2. The orphan designation criteria remain largely unchanged, meaning…

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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 EU Pharmaceutical Package

A New Dawn for the EU Pharma Regulatory Regime? The Commission’s Proposal to Revise the EU Pharmaceutical Legislation is Finally Published

by , and 5 Mins Read

Today the European Commission has finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous reform for over 20 years. This is an eagerly anticipated overhaul of the EU’s pharmaceutical system that has generated a lot of debate and concern since earlier leaked documents showed the far-reaching effect of the measures that were being considered and the impact these could have on the industry. The review is part of the EU’s Pharmaceutical…

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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

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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 Medical Devices

EU MDR Amendment Enters Into Force: What Does This Mean for your Legacy Devices?

by , , and 3 Mins Read

In brief The amendment to the Medical Device Regulation 2017/745 (MDR) and the In Vitro Medical Device Regulation 2017/746 (IVDR) has been published and enters into force immediately (20 March 2023). What does this mean for your organisation? The amendment extends transitional periods under the MDR for legacy devices (if manufacturers act now) and removes the “sell-off” date under the MDR and IVDR. We’ve set out our top four takeaways below: 1. New extended transitional…

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In Digital Health

Ethical AI Meets the EU AI Act: What Does This Mean for Healthcare Organisations?

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The European Union’s draft AI Act is an ‘early-mover’ in the arms race towards a global blueprint for AI regulation. In December 2022, the European Council approved a compromise version of the AI Act, and next month, the European Parliament is scheduled to vote on the draft text. But despite its initial promise, the AI Act increasingly resembles the circumstances of its conception – a complex, one-time political compromise between thousands of MEPs with wildly differing views.…

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In Pharmaceuticals & Biotech

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

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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)

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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 Digital Health

Decentralised Clinical Trials – 6 Takeaways from New EU Guidance

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In brief A new EU-level recommendation paper (“Paper”) sets out wide-ranging recommendations for sponsors of decentralized clinical trials (DCTs). The Paper is great news for sponsors facing an array of grey areas and gaps in regulatory guidance around DCTs. It provides guidance on common issues in designing and implementing DCTs: from documenting the delegation of tasks to digital service providers, to obtaining e-consents and how investigators should manage new streams of incoming data. The recommendations…

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In Pharmaceuticals & Biotech

The UK’s Voluntary Scheme for Branded Medicines Pricing and Access rate set to rise (again), to 26.5% for 2023

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The UK’s Department of Health and Social Care has announced that the voluntary scheme payment percentage (VPAS) for 2023 will be set at 26.5% of sales for 2023 (representing almost GBP 3.3 billion). This is a further major increase to last year’s VPAS significant rate rise to 15% (around GBP 1.8 billion, rising from GBP 0.6 billion in 2021). VPAS is an agreement between the Department of Health and Social Care (DHSC), NHS England and…

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