Good clinical practice (GCP) meaning

In this issue: Competition in life sciences Disputes and regulatory enforcement Medical devices Research and development Advanced therapeutics Borderline products Post-market Pharmaceuticals—regulatory framework Daily and weekly news alerts New and updated content Trackers Useful information Competition in life sciences EU introduces competitiveness compass The European Commission has unveiled the competitiveness compass, a strategic blueprint to steer its work over the next five years, setting out priority measures to strengthen Europe’s competitiveness. This constitutes the Commission’s first major initiative of the current mandate. Building on the recommendations in the Draghi report, ‘The future of European competitiveness’, released in September 2024 (see: LNB News 10/09/2024 44), the compass seeks to place Europe at the forefront of developing, manufacturing and marketing next‑generation technologies, services and clean products, while delivering climate neutrality. Although productivity growth has trailed other leading economies during the past two decades, the EU retains the means to reverse course, including a...

In this issue: Intellectual property Medical devices Commercialisation Data protection and confidential information Pharmaceuticals—regulatory Research and development Daily and weekly news alerts New and updated content Trackers Latest Q&A Useful information Intellectual property Court of Justice sets an ‘invention’ benchmark for SPC eligibility in combination products. EU Law: Ravi Srinivasan and Graham Lewis, partners, and James Egleton and James Smythies, associates, at J A Kemp, examine the joined rulings in Teva and Merck, addressing how to judge the availability of supplementary protection certificates (SPCs) for fixed combination products. See News Analysis: Court of Justice introduces an ‘invention’ test for combination products to be eligible for SPC protection. Medical devices MHRA issues guidance on new Medical Devices Post-Market Surveillance requirements. The Medicines and Healthcare products Regulatory Agency (MHRA) has published a suite of guidance to help device manufacturers implement the new Post-market surveillance (PMS) Regulation SI for medical devices in Great Britain...

A–B | C–D | I–N | O–P | Q–V. Early access to medicines scheme Through the early access to medicines scheme (EAMS), the Medicines and Healthcare products Regulatory Agency (MHRA) permits patients with life‑threatening or seriously disabling conditions to obtain medicines that do not yet possess a marketing authorisation (MA) (or are not authorised for that use) where there is a clear and evident unmet medical need. For further details, consult Practice Notes: UK marketing authorisations for medicinal products—Early access to medicines scheme (EAMS)—exemption, and Unlicensed medicinal products and off‑label use of medicinal products—Early access to medicines scheme (EAMS)—UK regime, plus MHRA guidance: Apply for the early access to medicines scheme (EAMS). EFPIA Code The EFPIA Code is a set of industry self‑regulatory ethical standards that govern the promotion of prescription‑only medicines (POMs) by all European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies in their interactions with healthcare professionals (HCPs), healthcare organisations (HCOs), patients’ organisations (POs) and the general public too. This...

The highly regulated nature of the life sciences industry Intense regulation within life sciences creates countless avenues for enforcement where ethical standards or legal duties are breached. Organisations must understand and meet their compliance responsibilities, and, at times, those affected by regulatory action may seek to contest the outcome. Sanctions can compel a life sciences company to undertake expensive remediation, pay heavy penalties and endure damaging negative press. They can also strain contractual and trading arrangements; moreover, those under supervision must manage continuing relationships with regulators with care. Operators spanning the UK and EU require insight into domestic requirements and the stance adopted by local authorities. Clients now encounter escalating enforcement exposure, intersecting frameworks and tangible individual and corporate liability. Enforcement risk in life sciences is no longer compartmentalised. If matters unravel, the fallout is rapid, visible and costly. Consequences are fast, public and costly for organisations and individuals alike within the sector. This Practice Note delivers a thorough, hands-on synopsis of enforcement, compliance duties and dispute resolution routes...