MHRA Safety Roundup May 2025 MHRA's safety bulletin, the MHRA Safety Roundup, for May 2025 has been published. This includes a summary of all safety alerts (including Drug Safety Updates) published during the month for medicines and medical devices. MHRA Safety Roundup May 2025
EU – COMBINE Program for Clinical Trials and Medical Devices – Pilot Launch As part of the COMBINE programme, Member State authorities have launched a pilot to test a new, more efficient way of approving combined studies. EU – COMBINE Program for Clinical Trials and Medical Devices – Pilot Launch
EMA Management Board – June 2025 – Meeting highlights The highlights of the European Medicines Agency (EMA) Management Board June 2025 meeting have been published. EMA Management Board – June 2025 – Meeting highlights
MHRA Publishes Marketing Authorisations Granted 15 May to 31 May 2025 MHRA granted 5 OTC licences during 15-31 May 2025. MHRA Publishes Marketing Authorisations Granted 15 May to 31 May 2025
MHRA – Updated Guidance on Supplying Authorised Medicines to Northern Ireland MHRA has updated the guidance on supplying authorised medicines to Northern Ireland. An overview has been added and sections 2, 3 and 4 have been updated to reflect the implementation of the Windsor Framework on 1 January 2025. MHRA – Updated Guidance on Supplying Authorised Medicines to Northern Ireland
MHRA RegulatoryConnect Webinar Recording MHRA has published the recording of the RegulatoryConnect webinar which took place on 22 May 2025. MHRA RegulatoryConnect Webinar Recording
EMA HMPC Consultation – Data Recommendations for Herbal Medicinal Products Use in Children and Adolescents The HMPC has opened a consultation on its draft reflection paper on data recommendations for herbal medicinal products used in children and adolescents. EMA HMPC Consultation – Data Recommendations for Herbal Medicinal Products Use in Children and Adolescents
CMDh May 2025 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the CMDh meeting held on 20-21 May 2025. CMDh May 2025 Meeting – Report
EMA HMPC Meeting Report – May 2025 The report from the EMA Committee on Herbal Medicinal Products (HMPC) meeting held on 5-7 May 2025 has been published. EMA HMPC Meeting Report – May 2025
JRC Consultation on EU Harmonised Label for Packaging Waste The Joint Research Centre (JRC) of the European Commission has launched a targeted stakeholder consultation as part of their technical work on the harmonised label. The survey aims to gather more detailed feedback on the design aspects of material-based waste sorting labels to be applied to product packaging and waste receptacles across the EU. The deadline to respond is 16 June. JRC Consultation on EU Harmonised Label for Packaging Waste
MHRA Marketing Authorisations Granted 1 to 14 May MHRA granted 4 OTC licences during 1 to 14 May 2025. MHRA Marketing Authorisations Granted 1 to 14 May
MHRA Webinar on New National Assessment Procedure for Medicines – Recording Available The recording of MHRA webinar on 'new national assessment procedure for medicines' is now available on Youtube. MHRA Webinar on New National Assessment Procedure for Medicines – Recording Available
