Request for a Preliminary Ruling to the European Court of Justice – Distinction Between Food for Special Medical Purposes, Food Supplements and Medicinal Products Request for a Preliminary Ruling to the European Court of Justice (Case C-760/21) – Distinction between Food for Special Medical... Request for a Preliminary Ruling to the European Court of Justice – Distinction Between Food for Special Medical Purposes, Food Supplements and Medicinal Products
MHRA – UK Early Access to Medicines Scheme Consultation Outcome MHRA – UK Early Access to Medicines Scheme Consultation Outcome The MHRA ran a public consultation on a proposed statutory... MHRA – UK Early Access to Medicines Scheme Consultation Outcome
EMA Report – Learnings Initiative for Optimal Use of Big Data for Regulatory Purpose Workshop EMA Report – Learnings Initiative for Optimal Use of Big Data for Regulatory Purpose Workshop On 30 November 2021 EMA... EMA Report – Learnings Initiative for Optimal Use of Big Data for Regulatory Purpose Workshop
MHRA Public Consultation on Reclassification of Gina 10 Microgram Vaginal Tablets (Estradiol) to a Pharmacy Medicine MHRA Public Consultation on Reclassification of Gina 10 Microgram Vaginal Tablets (Estradiol) to a Pharmacy Medicine The MHRA has lauched... MHRA Public Consultation on Reclassification of Gina 10 Microgram Vaginal Tablets (Estradiol) to a Pharmacy Medicine
EU Clinical Trials Information System – Live 31 January 2022 EU Clinical Trials Information System – Live 31 January 2022 The Clinical Trials Information System (CTIS) went live on 31... EU Clinical Trials Information System – Live 31 January 2022
CMDh January 2022 Meeting – Report CMDh January 2022 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published... CMDh January 2022 Meeting – Report
EMA Reinforced Role for Emergency Situations – Regulation Published in Official Journal EMA Reinforced Role for Emergency Situations – Regulation Published in Official Journal The Regulation (EU) 2022/123 of... EMA Reinforced Role for Emergency Situations – Regulation Published in Official Journal
HPRA – Guidance Update HPRA – Guidance Update The Health Products Regulatory Authority (HPRA) has updated some of their guidance documents. Please find the... HPRA – Guidance Update
MHRA Guidance Published – Risk-Adapted Approach to Clinical Trials and Risk Assessments MHRA Guidance Published – Risk-Adapted Approach to Clinical Trials and Risk Assessments The MHRA has published guidance on Risk-Adapted Approach... MHRA Guidance Published – Risk-Adapted Approach to Clinical Trials and Risk Assessments
MHRA Guidance Published – Oversight and Monitoring of Investigational Medical Product Trials MHRA Guidance Published – Oversight and Monitoring of Investigational Medical Product Trials The MHRA has published oversight and monitoring of... MHRA Guidance Published – Oversight and Monitoring of Investigational Medical Product Trials
EU Commission – Public Consultation on REACH Regulation Revision EU Commission – Public Consultation on REACH Regulation Revision The European Commission has launched a public consultation... EU Commission – Public Consultation on REACH Regulation Revision
Webinar on Responsible Manufacturing Effluent Management Technical Guidance Webinar on Responsible Manufacturing Effluent Management Technical Guidance On Friday 18 February 2022 AESGP, EFPIA and Medicines for Europe are... Webinar on Responsible Manufacturing Effluent Management Technical Guidance