New Guidance for HMA-EMA Catalogues of RWD Sources and Studies New guidance has been published to provide best practices for users of the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) Catalogues of real-world data (RWD) sources and studies (RWD Catalogues). The RWD Catalogues, launched a year ago, aim to enhance transparency and access to RWD for research and regulatory purposes. New Guidance for HMA-EMA Catalogues of RWD Sources and Studies
EMA – QRD Template & KIS Consultations The European Medicines Agency (EMA) has released the draft revised QRD template for consultation, the deadline is 31 August. In addition, EMA is running a public consultation on the potential inclusion of a ‘key information section’(KIS) in the package leaflet of centrally authorised medicines. The deadline is 31 May. EMA – QRD Template & KIS Consultations
Consultation on Draft Revised EU Herbal Monographs for Garlic, Arnica and Hawthorn Draft revised EU herbal monographs on Garlic, Arnica Flower and Hawthorn Leaf and Flower have been published for public consultation. Consultation on Draft Revised EU Herbal Monographs for Garlic, Arnica and Hawthorn
CHM Appointments Professor Claire Stewart has been appointed as a commissioner of the Commission on Human Medicines (CHM) for 4 years from 3 March 2025. In addition, 3 other commissioners have been reappointed, with their new terms due to begin in May. CHM Appointments
MHRA Performance Data – March 2025 The Medicines and Healthcare products Regulatory Agency (MHRA) has published its performance data for March 2025. MHRA Performance Data – March 2025
MHRA Statement on Products Containing Cannabidiol (CBD) The Medicines and Healthcare products Regulatory Agency (MHRA) has published its opinion on the regulatory status of products containing CBD. MHRA Statement on Products Containing Cannabidiol (CBD)
EMA Consultation – Reflection Paper Linking to ePI from EU Medicine Packages The European Medicines Agency (EMA) has released for public consultation its Reflection paper on linking to electronic product information (ePI) from EU medicine packages. The official deadline for comments is 30 June 2025. EMA Consultation – Reflection Paper Linking to ePI from EU Medicine Packages
UK Clinical Trials Regulations Signed into Law New regulations for running clinical trials in the UK have now been signed into law. A 12-month roll-out began on 11 April to deliver a significant update to UK clinical trials regulation, with the aim of strengthening patient safety, accelerating approvals, enabling innovation and helping more people benefit from taking part in vital research. UK Clinical Trials Regulations Signed into Law
DHSC – Value Based Procurement Market Engagement Exercise One of the Department of Health and Social Care (DHSC)'s key MedTech initiatives is Value Based Procurement (VBP). The DHSC VBP team are hosting 2 hour long Q&A sessions with MedTech suppliers. The sessions will take place on 7 May 11am - 12pm and 13 May 3 - 4pm. DHSC – Value Based Procurement Market Engagement Exercise
DBT – Request for Input on Potential UK Measures in Response to US Tariffs The Department for Business and Trade (DBT) is seeking input from stakeholders on potential UK measures in response to recent US tariff announcements. DBT – Request for Input on Potential UK Measures in Response to US Tariffs
EU Life Sciences Strategy – Call for Evidence The European Commission has opened a Call for Evidence on the EU Life Sciences Strategy, closing 17 April 2025. EU Life Sciences Strategy – Call for Evidence
EMA – Real-world Evidence The European Medicines Agency (EMA) has published a reflection paper on the use of real-world data in non-interventional studies to generate real-world evidence (RWE) and a document detailing progress and the journey towards a roadmap for regulatory guidance on RWE. EMA – Real-world Evidence
