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
EMA Variation Guideline Revision – Stakeholder Consultation The European Medicines Agency (EMA) has launched a stakeholder consultation on the revised European Commission guidelines on variations categories and procedures. EMA Variation Guideline Revision – Stakeholder Consultation
PAGB Food Supplements Regulatory Workshop The next PAGB Food Supplements Regulatory workshop will be held via Microsoft Teams on Thursday 4 July from 10am – 4pm. PAGB Food Supplements Regulatory Workshop
PMS PUI Read-only Mode Live on PLM Portal The read-only mode of the Product Management Service (PMS) is available for registered users and can be accessed through the Product User Interface (PUI) - live on the Product Lifecycle Management (PLM) Portal. Throughout June 2024, the PMS team will be running Q&A clinics on PUI. PMS PUI Read-only Mode Live on PLM Portal
PAGB Introduction to CBD Workshop The next PAGB Introduction to CBD workshop will be held via Microsoft Teams on Wednesday 5 June from 10am – 1pm. PAGB Introduction to CBD Workshop
MHRA Board Members and Committee Lists Updated The MHRA has updated the board members and committee list on their website. MHRA Board Members and Committee Lists Updated
ESMP Webinar The European Medicines Agency (EMA) is organising a series of events throughout 2024 and 2025 for stakeholders on the European Shortages Monitoring Platform (ESMP). The first webinar is scheduled for 24 June. ESMP Webinar
MHRA Marketing Authorisations Granted 1 to 14 May 2024 MHRA granted 6 OTC licenses during 1 - 14 May 2024. MHRA Marketing Authorisations Granted 1 to 14 May 2024
Brexit Working Group Meeting Michelle Riddalls, CEO of PAGB, hosted an ad hoc meeting of the EU Exit Working Group to update on the EU Acquis implementation for medicines within the Windsor Framework. Brexit Working Group Meeting
EMA Q&A Document on Article 117 – 4th Revised Version Published EMA has published the fourth revised version of its questions & answers document on Article 117 MDR (practical considerations concerning combination products). EMA Q&A Document on Article 117 – 4th Revised Version Published
