Herbal Medicines Granted a Traditional Herbal Registration MHRA has updated the list of herbal medicines currently holding a traditional herbal registration (THR) granted by the MHRA. Herbal Medicines Granted a Traditional Herbal Registration
CMDh July 2025 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from their meeting held on 14-15 October 2025. CMDh July 2025 Meeting – Report
ICH M14 Guideline Published – Pharmacoepidemiological Studies Using Real-world Data for Safety Assessment of Medicines The European Medicines Agency (EMA) has published the ICH M14 guideline on general principles on planning, designing, analysing and reporting of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines. ICH M14 Guideline Published – Pharmacoepidemiological Studies Using Real-world Data for Safety Assessment of Medicines
MHRA Performance Data – September 2025 MHRA has published its performance data for September 2025. MHRA Performance Data – September 2025
10-Year Health Plan – Recording of Webinar on How MHRA and NICE Will Bring Medicines to Patients Months Sooner The recording of the webinar on how the collaboration between MHRA and NICE will bring medicines to patients sooner is now available. 10-Year Health Plan – Recording of Webinar on How MHRA and NICE Will Bring Medicines to Patients Months Sooner
MHRA – Borderline Products Advice Form Updated MHRA has updated the medicines borderline advice form in their guidance 'borderline products: how to tell if your product is a medicine'. MHRA – Borderline Products Advice Form Updated
MHRA – Apply for a Variation to your Marketing Authorisation Guidance Updated MHRA has updated their guidance - 'Medicines: apply for a variation to your marketing authorisation'. MHRA – Apply for a Variation to your Marketing Authorisation Guidance Updated
Draft EU Herbal Monograph on Zea mays L. (Corn silk) Further to its adoption by the EMA Committee on Herbal Medicinal Products (HMPC) in September 2025, the draft European Union herbal monograph on Zea mays L., stigma has been published for public consultation. Draft EU Herbal Monograph on Zea mays L. (Corn silk)
PAGB Updated Briefing Paper on Titanium Dioxide PAGB's briefing paper – ‘PAGB overview relating to the ban of titanium dioxide in foods, including its potential impact on food supplements and medicines’ has been updated. PAGB Updated Briefing Paper on Titanium Dioxide
EMA HMPC Meeting Report – September 2025 The report on European Union herbal monographs, guidelines, and other activities from the European Medicines Agency (EMA) Committee on Herbal Medicinal Products (HMPC) meeting held on 22-24 September 2025 has been published. EMA HMPC Meeting Report – September 2025
MHRA Marketing Authorisations Granted 15 to 30 September 2025 MHRA granted 4 OTC licences during 15 - 30 September 2025. MHRA Marketing Authorisations Granted 15 to 30 September 2025
EUROTALC Scientific Position Published EUROTALC, the talc industry’s representative body for regulatory and scientific matters, has published its position regarding the European Chemicals Agency's (ECHA) Harmonised Classification Proposal of Talc. EUROTALC Scientific Position Published
