EMA Public Launch of Guideline on Good Pharmacovigilance Practices The European Medicines Agency (EMA) is hosting a virtual event on 11 September 2024 to present the revised Guideline on good pharmacovigilance practices (GVP) Module XVI and its Addendum II. EMA Public Launch of Guideline on Good Pharmacovigilance Practices
EMA-AESGP Bilateral – April 2024 – Highlights Published The European Medicines Agency (EMA) has published the highlights from the fifth EMA-AESGP bilateral meeting held on 29 April 2024. EMA-AESGP Bilateral – April 2024 – Highlights Published
CMDh June 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 25-26 June 2024. CMDh June 2024 Meeting – Report
EMA New Fee Regulation – Working Arrangements The European Medicines Agency (EMA) Management Board adopted several documents in June 2024 in preparation for the New Fee Regulation (Regulation (EU) 2024/568) on fees and charges payable to the Agency coming into effect as of 1 January 2025. EMA New Fee Regulation – Working Arrangements
Upcoming EMA Events on PMS, Pack Size Submissions, API, and SPOR EMA is organising three public events in July 2024 targeting Industry stakeholders including regulatory affairs, regulatory data management and regulatory systems sectors. Upcoming EMA Events on PMS, Pack Size Submissions, API, and SPOR
Revised EMA Q&A on Centrally Authorised Medicines Intended to be Placed on the Market in NI EMA has published a revised Q&As to Stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use. Revised EMA Q&A on Centrally Authorised Medicines Intended to be Placed on the Market in NI
TOPRA Symposium TOPRA is hosting their annual Symposium in Rotterdam, at the Postillion Hotel WTC, between 30 September and 2 October 2024. TOPRA Symposium
HPRA Windsor Framework Q&A Updated The Health Products Regulatory Authority, HPRA, has updated its Q&A document on the impact of the Windsor Framework. HPRA Windsor Framework Q&A Updated
MHRA Marketing Authorisations Granted 15 to 31 May 2024 MHRA granted 6 OTC licenses during 15-31 May 2024. MHRA Marketing Authorisations Granted 15 to 31 May 2024
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
ICH M14 Guideline – Pharmacoepidemiological Studies Using Real-world Data for Safety Assessment of Medicines The European Medicines Agency (EMA) has published for public consultation the ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines. ICH M14 Guideline – Pharmacoepidemiological Studies Using Real-world Data for Safety Assessment of Medicines
Draft EU Herbal Monographs on Prunus avium peduncle, Zingiberis rhizoma & Urticae radix The European Medicines Agency has published draft EU herbal monographs on Prunus avium peduncle, Zingiberis rhizoma and Urticae radix for public consultation. Draft EU Herbal Monographs on Prunus avium peduncle, Zingiberis rhizoma & Urticae radix
