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NEWS
Employment analysis: Caspar Glyn KC, Chair of the Employment Lawyers Association (ELA) and Olivia Dobbie, Management Committee Member of ELA, and Diversity Lead, have on 8 April 2025 published an 8–page statement on behalf of ELA regarding diversity, equity and inclusion (DEI) policies in England, Wales and Scotland (Great Britain). The statement highlights the danger of following the US in ‘rolling back’ DEI, the position in the US and Great Britain in relation to discrimination law and positive action, the legal risks that companies in Great Britain may face if they reverse their DEI policies, the questions to ask when operating DEI policies in accordance with the law, and the holistic benefits of DEI.
NEWS
The European Labour Authority (ELA), established in July 2019 under Regulation (EU) 2019/1149, has supported fair labour mobility and enforced EU labour and social security rules over its first five years by conducting 168 cross-border inspections that examined over 13,500 workers in high-risk sectors. A 2024 Commission evaluation, detailed in report COM(2025) 256 final, has confirmed these contributions and highlighted areas for improvement. The evaluation identified the need to enhance joint inspection practices, better address issues concerning third country nationals, improve personal data processing, and simplify access to mediation procedures. It also points to operational challenges in staffing, budget management, and the set-up process. In response, Executive Vice-President Roxana Mînzatu stated that the Commission will propose measures to reinforce ELA, including a potential review of its mandate, as part of a broader Fair Labour Mobility package planned for early 2026.
NEWS
The European Law Institute (ELI) has published its Principles Governing the Third Party Funding of Litigation (TPFL) as the final outcome of its TPFL project. The Principles are designed to provide guidance for litigants, funders, legal advisors, and regulatory bodies involved in TPFL agreements, with the intention of enhancing ‘transparency, fairness, and accessibility in litigation funding’. A range of specific types of proceedings are explored, as well as concepts such as Damages Based Agreements and Conditional Fee Agreements.
NEWS
The European Medicines Agency (EMA) has reported on 3 April 2025 that the Clinical Trials Information System (CTIS) has been designated as a primary registry within the World Health Organisation's (WHO) International Clinical Trials Registry Platform. The designation confirms CTIS meets WHO criteria for data quality, accessibility and administration. The status enables CTIS-registered trials to meet International Committee of Medical Journal Editors publication requirements. CTIS has served as a WHO data provider since May 2023 and succeeds the EU Clinical Trials Register, which held primary registry status since September 2011.
FLOWCHARTS
Regulation (EC) 1049/2001, the Access to EU Documents Regulation, provides a mechanism through which persons can request access to documents held by EU institutions on human and veterinary medicines (and documents not related to medicines). Article 4 of the Access to EU Documents Regulation provides a list of the
NEWS
The European Medicines Agency (EMA) has added a questions and answers (Q&A) section to its real-world evidence webpage to clarify regulatory aspects addressed by existing EMA guidance on the use of real-world data (RWD). The section covers definitions of RWD and real-world evidence, data quality considerations, feasibility assessments, publication requirements for study protocols and reports and key methodological aspects, including the target trial emulation framework. The Q&A refers to three existing guidance documents: EMA's reflection paper on the use of RWD in non-interventional studies, the guideline on registry-based studies and the HMA-EMA data quality framework for medicines regulation.
NEWS
The European Medicines Agency (EMA) has adopted a guideline outlining quality, non-clinical, and clinical requirements for investigational advanced therapy medicinal products (ATMPs) in clinical trials. The guideline, effective from 1 July 2025, covers gene therapy, cell therapy, tissue engineered products, and combined ATMPs. EMA has emphasised a risk-based approach for data evaluation and the importance of quality development. The agency has incorporated public feedback, including references to ICH E11 guidance for paediatric populations and device-drug combination ATMPs. EMA encourages early guidance seeking and notes that inadequate quality development may compromise clinical trial data usability for marketing authorisation applications.
NEWS
The European Medicines Agency (EMA) has adopted a reflection paper on using AI and machine learning (ML) in drug development after considering extensive feedback during the consultation period with revision to key parts. The updated paper also includes changes based on the recent EU AI Act.
NEWS
The European Medicines Agency (EMA) has launched its first social media campaign working with content creators to promote safe use of GLP-1 receptor agonists. The #HealthNotHype campaign partners with healthcare professionals and nutrition experts from seven EU Member States on Instagram to address misinformation about these diabetes and weight management medicines. The month-long campaign, which began on 21 October 2025, involves content creators with a combined following of approximately 1.4 million users posting audiovisual content and conducting interactive polls. EMA selected creators based on their credibility in healthcare communication and alignment with evidence-based information principles. Separately, the European Federation of Pharmaceutical Industries and Associations (EFPIA) announced a partnership with TikTok on 21 October 2025 to combat counterfeit medicine sales through its 'Don't fall for dupes' campaign, highlighting that over 50% of medicines sold online are counterfeit.
NEWS
The The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly published ten guiding principles for good artificial intelligence (AI) practice in medicines development on 14 January 2026. The principles apply across the entire medicines lifecycle and are intended to inform future regulatory guidance in multiple jurisdictions, including forthcoming EU guidelines.
NEWS
The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have published a draft data standards framework for consultation. The framework proposes a common governance process for adopting, developing, updating and implementing data standards across the European medicines regulatory network (EMRN) for human and veterinary medicines. It gives the Network Data Steering Group responsibility for reviewing and prioritising proposals from the EMRN, its stakeholders, international harmonisation bodies and standards development organisations. The framework promotes open, high-quality international standards, data protection and ethics by design, stakeholder collaboration and the avoidance of overlapping standards. It also requires implementation needs, including changes to IT systems and business processes, to be considered from the start. Defined roles and tracking arrangements are intended to replace the previous fragmented approach, reduce resource requirements and shorten implementation times. The consultation closes on 18 September 2026.
NEWS
The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) released a joint warning on 13 March 2025 regarding unregulated advanced therapy medicinal products (ATMPs) in the EU market. The statement clarifies that ATMPs can only be legally supplied through central EMA authorisation, authorised clinical trials, or specific national authority exemptions. Authorities are particularly concerned about unregulated dendritic cell cancer therapies being marketed directly to patients. The warning emphasises increased enforcement actions against illegal suppliers and requests public reporting of suspicious cases to national competent authorities.