MHRA Performance Data for Assessment of Clinical Trials and Established Medicines The MHRA performance metrics for clinical trials and established medicines assessment have been updated. MHRA Performance Data for Assessment of Clinical Trials and Established Medicines
Established Medicines Marketing Authorisation Application Process Changes – Guidance Update MHRA has updated guidance on the details of the process changes for “Established Medicines”, effective from 1 March 2024, which apply specifically to ‘chemical’ products. Established Medicines Marketing Authorisation Application Process Changes – Guidance Update
UK REACH: Rationale for priorities Defra, and the Scottish and Welsh Governments have set out a rationale for the UK REACH work programme UK REACH: Rationale for priorities
MHRA Marketing Authorisations Granted 15 to 29 February 2024 MHRA granted four OTC licenses in January 2024. MHRA Marketing Authorisations Granted 15 to 29 February 2024
Final Revised EU Herbal Monographs on Sweet Fennel & Bitter Fennel Published EMA HMPC has published two revised EU herbal monographs. Final Revised EU Herbal Monographs on Sweet Fennel & Bitter Fennel Published
Established Medicines Marketing Authorisation Application Process – MHRA Guidance Published New process changes have been introduced for applications for marketing authorisations for 'Established Medicines' to help assess applications more efficiently. Established Medicines Marketing Authorisation Application Process – MHRA Guidance Published
CMDh February 2024 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the CMDh meeting held on 20-22 February. CMDh February 2024 Meeting – Report
Defra Animal Product Imports Webinars Register now for Defra animal product imports webinars. Defra Animal Product Imports Webinars
MHRA RegulatoryConnect Webinar MHRA Webinar on the Introduction to the RegulatoryConnect portal. MHRA RegulatoryConnect Webinar
EMA HMPC Call for Scientific Data The European Medicines Agency's (EMA) Committee on Herbal Medicinal Products (HMPC) has launched calls for submission of scientific data. EMA HMPC Call for Scientific Data
MHRA First Approval via New IRP in 30 Days MHRA has granted the first approval via the new International Recognition Procedure (IRP) in 30 days. The IRP was launched in January 2024 and aims to help bring life-saving new medicines to UK patients without delay. MHRA First Approval via New IRP in 30 Days
MHRA Chief Executive Dame June Raine to Step Down Dame June Raine, MHRA's Chief Executive, will be stepping down in the Autumn following 5 years in the role. MHRA Chief Executive Dame June Raine to Step Down
