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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)

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 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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In Pharmaceuticals & Biotech

European Court of Justice upholds strict interpretation of medicines advertising to the general public

by 4 Mins Read

The European Court of Justice (the “Court”) has upheld the lawfulness of a Latvian law banning any advertising of medicinal products to the general public that encourages purchases by offering discounts and other special price offers, including reduced bundled pricing. The Court goes as far as saying that Member States must ban such advertising, even if not expressly prohibited by EU harmonising rules, where that is necessary to prevent the irrational use of medicines that…

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In Medical Devices

Italy: National Coordination Centre for Ethics Committees updates the documentation relating to clinical trials and investigations

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In brief On 10 November 2022, the National Coordination Centre for Ethics Committees (“Centre”) published the updated versions of the “Contract for the performance of clinical trials on medicines,” the “Contract for the performance of independent clinical trials on medicines” and the “Contract for the performance of clinical investigations on medical devices that are not CE marked or CE marked but used outside their intended use.” Key takeaways In particular, the updates relate to: (i)…

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In Pharmaceuticals & Biotech

Ukraine overhauls pharmaceuticals regulatory framework: New pharmaceuticals law to be enacted post-war

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Ukraine has adopted the new law on pharmaceuticals (“Law”) that fundamentally changes the regulatory framework for pharmaceuticals. The Law is largely based on EU laws, although certain provisions, including as regards parallel importation of pharmaceuticals and regulatory data protection, are not aligned with EU laws and may create hurdles for companies operating in the Ukrainian market. The Law will be enacted within 2.5 years after the expiry/lifting of martial law. In this video, we present these and…

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In Pharmaceuticals & Biotech

Spain Speeds up the Application Process for EU Centrally Authorised Medicinal Products (EU-CAPs)

by 5 Mins Read

In brief The Spanish Agency for Medicines and Health Products has streamlined the procedure for applying for the national code (NC) of centrally authorized medicinal products. In order to have more efficient management, this change has been included in a guide containing information on the documents required for the assignment of the NC. From now on it will be possible to send the NC application as soon as the final texts have been adopted by…

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In Digital Health

How Will Pharma Use Health Data for Clinical Trials in the Future? The Power of Clinical Trial Tokenisation

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In brief On 25 October 2022 leading researchers and executives from some of the world’s pioneering drug and pharmaceutical companies came together at a Financial Times Live Webinar event to discuss “The Power of Clinical Trial Tokenisation”. Tokenisation of healthcare data is likely to be one of the next great innovations for developing life-saving drugs and treatments through the method of privacy-preserving record linkage (PPRL). This allows pharmaceutical companies to “tokenise” and link previously scattered…

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In Healthcare Services

Switzerland Adopts New Human Genetic Testing Act

by and 7 Mins Read

In brief On 1 December 2022, Switzerland’s new Human Genetic Testing Act (HGTA) will enter into force. The new HGTA provides a comprehensive legal framework for all types of genetic testing (including direct-to-consumer genetic testing and lifestyle genetic testing) and implements stronger measures to protect privacy rights, prevent abuse of genetic data and ensure the quality of genetic tests and the interpretation of the results. As part of the comprehensive revision of the HGTA, the…

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