EMA – Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®) EMA – Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®) The European Medicines Agency (EMA)... EMA – Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®)
EMA HMPC Meeting Report – January 2022 EMA’s Committee on Herbal Medicinal Products (HMPC) has published the report from their January 2022 meeting EMA’s Committee on Herbal... EMA HMPC Meeting Report – January 2022
Recent updates to MHRA guidance – what has changed Recent updates to MHRA guidance – what has changed The MHRA has shared a summary overview of recent updates to... Recent updates to MHRA guidance – what has changed
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
