EMA Guideline on Environmental Risk Assessment for Medicinal Products EMA has published a guideline on the environmental risk assessment of medicinal products for human use. EMA Guideline on Environmental Risk Assessment for Medicinal Products
RegulatoryConnect Portal The MHRA’s new RegulatoryConnect portal and its first services will be available to customers from Monday 25 March 2024. RegulatoryConnect Portal
EMA Management Board – March 2024 Meeting Highlights The European Medicines Agency (EMA) has published the highlights of the EMA Management Board meeting that took place on 21 March 2024. EMA Management Board – March 2024 Meeting Highlights
UK ePI Task Force March 2024 Bulletin The UK ePI Task Force has provided an update on recent Task Force activity. UK ePI Task Force March 2024 Bulletin
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