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On 7 July 2025, the European Commission launched a public consultation that could mark the start of a turning point for how Artificial Intelligence (AI) is used in pharmaceutical manufacturing. The consultation proposes significant updates to the EU Good Manufacturing Practice (GMP) guidelines—specifically Chapter 4 on Documentation, Annex 11 on Computerised Systems, and, for the first time, a new Annex 22 dedicated to AI.Continue Reading EU Consults on New GMP Rules for AI in Pharma Manufacturing

The European Medicines Agency (EMA) has published a draft Reflection Paper proposing a streamlined pathway for the approval for certain biosimilar medicinal products (biosimilars) in the EU by reducing the clinical data requirements where justified.

Biosimilars are biological medicinal products that are demonstrated to be highly similar to an already authorised biological medicinal product, known as the reference medicinal product (RMP), with no clinically meaningful differences in terms of quality, safety, or efficacy. Biosimilar marketing authorisation applications are subject to reduced data requirements compared to a full application. However, the applicant must submit a data package from a comparability exercise demonstrating that the purported biosimilar is highly similar to the RMP. Typically, this will require a comparative Clinical Efficacy Study (CES) to confirm the similarity (though this requirement can already be waived in certain circumstances).

In its Reflection Paper, the EMA sets out the prerequisites for more general principles for when requirements for a CES may be waived, and only a limited, targeted clinical data package (based on a comparative pharmacokinetic (PK) trial) will be accepted. Where this approach is adopted, this is likely to reduce the clinical development burdens for biosimilar companies.Continue Reading The European Medicines Agency Proposes Streamlined Pathway for the Approval of Biosimilar Medicinal Products in the EU

The European Commission (‘Commission’) has published a Questions & Answers (‘Q&A’*) document on the new obligation to notify interruptions or discontinuations of the supply of medical devices under the Medical Devices Regulation (Regulation (EU) 2017/745, ‘MDR’) and the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746, ‘IVDR’).

This new reporting obligation is set out in the newly introduced Articles 10a in both the IVDR and the MDR, as amended by Regulation (EU) 2024/1860. This obligation will start to apply on 10 January 2025.

Our blog focuses on the key requirements applying to manufacturers, and how these align with  the European Medicines Agency’s (‘EMA’) role to monitor medical device shortages.Continue Reading Medical devices: European Commission issues Q&A on the obligation to notify supply interruptions and discontinuations

This digest covers key virtual and digital health regulatory and public policy developments during September and early October 2024 from the United Kingdom and European Union.

Guidance on AI continues to be published. In the EU, the European Medicines Agency (EMA) has published its Reflection Paper on the use of AI throughout the medicines life cycle. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) opened applications for its AI Airlock, a regulatory sandbox for AI as Medical Devices. And over 100 companies have signed up to join the EU AI Pact, a voluntary initiative to encourage companies to comply with the AI Act before the statutory deadlines. These guidance documents and initiatives provide companies with much greater clarity on how the authorities will regulate the use of AI in health care.Continue Reading Virtual and Digital Health Digest – October 2024

Earlier this week, the EMA published its Reflection paper on the use of AI in the medicinal product life cycle. As set out in our previous blog post, the EMA’s draft reflection paper was published for consultation in July 2023, and following many months of review of the feedback collected from the relevant stakeholders, the Paper has now been published.  The Paper reflects the views of the EMA on the use of AI from drug discovery and non-clinical development, to clinical trials, manufacturing and post-authorisation. The Paper recognises the utility of AI in digital transformation and notes new risks that need to be mitigated to ensure patient safety and data integrity.Continue Reading EMA adopts reflection paper on the use of Artificial Intelligence (AI)

On 5 September 2024, the European Medicines Agency (EMA) and the Heads of Medicine Agencies (HMA) published a guidance document (the Guidance) with general principles and recommendations on the use of large language models (LLMs) in regulatory science and the regulation of medicinal products.  The guiding principles for users are also summarised in a one-page factsheet.

While the Guidance is aimed at the European Union (EU) regulatory authorities, it is instructive for companies active in the Life Sciences sector. It provides useful insight into how regulators will approach the use of LLMs in their regulatory activities, the risks they have identified and how these risks can be mitigated.

The development of the guiding principles set out in the Guidance are part of the EMA’s and HMA’s multiannual AI workplan to 2028 and, according to EMA, will be subject to regular future updates.Continue Reading AI: EMA publishes guiding principles on the use of large language models (LLMs)

The revised transparency rules governing the transparency of information submitted to the Clinical Trial Information System (CTIS), as adopted by the European Medicines Agency (EMA) on 5 October 2023, will come into effect on 18 June 2024, thesame day thenew CTIS portal will launch. The CTIS, established under the Clinical Trials Regulation (EU) No 536/2014 (CTR), aims at facilitating the information exchange on trials in the European Union (EU). It operates on the principle of public disclosure, with the exception of information relating to personal data and Commercially Confidential Information (CCI).

Preparation is crucial for sponsors conducting clinical trials in the EU as they may need to adapt ongoing trial documentation and future submissions. Our blog post sets out the key changes and provides tips for preparation.Continue Reading Getting Ready for the Upcoming Revised EMA CTIS Transparency Rules

On 5 April 2024, the MHRA updated various guidance documents on the impact of the Windsor Agreement (the Agreement) on parallel imports into and within the UK. Since the end of the Brexit transition period, EMA-issued parallel distribution notices (PDNs) ceased to be valid in Great Britain (GB). A PDN must be obtained by a parallel distributor prior to engaging in parallel distribution in the EU. In GB, PDNs were replaced by Parallel Import Licences (PLPIs), which allowed distribution of products in GB only; while PDNs continued to be valid in Northern Ireland (NI).

As of 1 January 2025, when the Agreement is due to take effect, PDNs will no longer be valid in NI. All parallel imports into GB and NI will require a PLPI from the MHRA that will apply across the whole UK, and any PLPIs that were previously limited to GB will automatically convert into UK-wide PLPIs from this date.Continue Reading Brexit update: Changes to parallel imports in the UK

On 12 December 2023, the European Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) published the first version of the Union list of critical medicines (the list). Along with the list, the EMA published a Questions & Answers document (Q&A).Continue Reading European Commission, HMA and EMA Publish First Union List of Critical Medicines

On 24 October 2023, the European Commission published a Communication on “Addressing medicine shortages in the EU” (the Communication). The Communication responds to the European Council’s call in June for urgent measures to ensure production and availability of critical medicines (i.e., the unavailability of which may cause patients serious harm, and whose supply must be ensured even in crisis periods) and to diversify international supply chains. On the same date, the European Medicines Agency (EMA) published details on the Solidarity Mechanism, recently created by the EMA Medicines Shortages Steering Group (MSSG) to facilitate redistribution of medicines between Member States (MS) in cases of critical shortages (i.e., medicine shortages where no alternative is available).

These EU-level actions are in addition to the mechanisms to tackle shortages already included in the European Commission’s proposal for a reform of the EU Pharmaceutical Legislation (read our advisory).Continue Reading New EU-level actions addressing shortages