Pricing, reimbursement and imports

Commercialisation of medicinal products and medical devices

Medicinal products cannot be placed on the market without having first obtained an approval known as a marketing authorisation (MA) and medical devices require a declaration of conformity and should be affixed with a CE mark before being placed on the market.

However, even when the regulatory requirements for marketing medicinal products and medical devices have been met, commercialisation requires consideration of issues regarding their manufacture, naming, packaging, pricing, distribution and sale.

For an overview of the typical lifecycle of a medicinal product, which sets out the key research, development, manufacture, marketing, sale and post-market steps, see: Lifecycle of a pharmaceutical product—flowchart.

For an overview of the typical lifecycle of a medical device, see: Lifecycle of a medical device—flowchart, which sets out key regulatory stages from concept and prototype design through its manufacture and placing on the market for patient use and post-market surveillance.

Commercial arrangement

The life sciences sector uses a variety of different commercial arrangements to govern the mechanics of manufacturing, selling and distributing products. These arrangements will, typically, also deal with the intellectual property (IP) in

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Latest Life Sciences News

Commission publishes updated clinical trials guidance package

The European Commission's Directorate-General for Health and Food Safety has published a comprehensive package of updated clinical trials guidance documents, all endorsed by the Clinical Trials Coordination and Advisory Group (CTAG) on 15 October 2025. The package includes new recommendations on criteria for selecting a reporting Member State under Article 85(2)(c) of the Clinical Trials Regulation, establishing a workshare criterion when proposed reporting Member States decline the role, which occurs in approximately 30% of applications. The Commission has updated its recommendation paper on decentralised elements in clinical trials (Version 02), superseding the December 2022 version, with revised national provision overviews and guidance on informed consent, investigational medicinal product delivery, and remote monitoring. A new recommendation paper addresses frequent issues identified during Part I and Part II assessments, based on feedback from national competent authorities and ethics committees, covering investigational medicinal product dossiers, protocols, and safety reporting. The package also includes revised guidance on auxiliary medicinal products, effective 1 December 2025 for new applications, featuring an updated classification system distinguishing between authorised, modified authorised, and unauthorised auxiliary medicinal products with corresponding application and safety reporting requirements.

Life Sciences weekly highlights—30 October 2025

This week's edition of Life Sciences weekly highlights includes a Law360 analysis of the Court of Justice upholding a €60.5m fine against Teva and Cephalon in a long-running pay-for-delay case involving a generic version of a blockbuster narcolepsy treatment, and an MLex analysis reporting that the European Commission is considering changes to how the EU AI Act applies to products regulated under sector-specific legislation, such as medical devices, as part of a wider digital ‘omnibus’ package expected on 19 November 2025. Also included is news that MedTech Europe has called for EU rules changes to permit electronic instructions for use (eIFUs) for near-patient testing devices, also known as point-of-care (POC) testing, the MHRA announced a new AI-driven project to predict drug interaction side effects, and together with the Health Research Authority (HRA) outlined preparations for clinical trials reform due to take effect from 28 April 2026, including the establishment of an advisory group on simplified arrangements for consent in low intervention clinical trials, the EMA opened a consultation on the use of non-human primates in safety testing and implementation of the 3Rs (replacement, reduction and refinement) principles, as well as news that the Health Economics Methods Advisory (HEMA) has published its first draft report for public comment on the factors that should be considered in health technology assessment (HTA) and the MHRA Criminal Enforcement Unit dismantled the UK’s first major illicit manufacturing facility distributing unlicensed weight loss jabs, among other stories.

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