Application Route for Performance Studies Under the In Vitro Diagnostics Regulations in Northern Ireland The MHRA has announced the approval of the first application for In Vitro diagnostic devices under the EU IVDR in Northern Ireland due to recent implementation of a submission route for manufacturers for performance studies. Application Route for Performance Studies Under the In Vitro Diagnostics Regulations in Northern Ireland
MHRA Strategy for Improving Safety Communications 2024 – 2027 MHRA has published their 3-year strategy for improving safety communications for 2024 to 2027. The strategy sets out MHRA’s ambition to transform the way they communicate about the risks and safety of medicines, medical devices and healthcare products in the UK to support effective implementation of new safety measures. MHRA Strategy for Improving Safety Communications 2024 – 2027
MHRA Data Strategy 2024 – 2027 Published MHRA has published its its data strategy 2024-2027. MHRA Data Strategy 2024 – 2027 Published
MHRA Webinar “Medicines Pipelines – MHRA’s new forecasting process” MHRA Webinar on medicines pipelines and MHRA’s new forecasting process MHRA Webinar “Medicines Pipelines – MHRA’s new forecasting process”
MHRA Windsor Framework Webinar MHRA is running a Windsor Framework Industry Webinar between 10:30am – 12:00pm on Thursday 19 September 2024. MHRA is now able to offer more spaces for the event. The aim of this webinar is to ensure the industry is best placed to understand changes made to guidance and make any relevant changes themselves in preparation for the Windsor Framework implementation date. MHRA Windsor Framework Webinar
PAGB Food Supplements Regulatory Workshop The upcoming PAGB Food Supplements Regulatory Workshop will take place in person on Thursday, 10 October, at PAGB's office from 10:00 AM to 4:00 PM. PAGB Food Supplements Regulatory Workshop
Public Consultation on EMA Draft Q&A: Co-Processed Excipients in Solid Oral Dosage Forms The European Medicines Agency (EMA) has published the draft questions and answers regarding co-processed excipients used in solid oral dosage forms for public consultation. Public Consultation on EMA Draft Q&A: Co-Processed Excipients in Solid Oral Dosage Forms
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
PAGB Webinar: Electronic Patient Information – the way forward for OTC medicines? As part of the new series of webinars, exclusive for PAGB members, we’re tackling important issues on the environment and sustainability in consumer healthcare. Join us for our next free webinar in the series on 2 October which will focus on Electronic Patient Information (ePI). PAGB Webinar: Electronic Patient Information – the way forward for OTC medicines?
2024 DSIT Research and Innovation Workforce Survey The Department for Science, Innovation and Technology (DSIT) is conducting the 2024 Research and Innovation (R&I) Workforce Survey. The results will impact UK government policy and R&D funding decisions. 2024 DSIT Research and Innovation Workforce Survey
Windsor Framework – Guidance Update The MHRA has updated its collection with new guidance for wholesalers and manufacturers, following the agreement on the Windsor Framework. Windsor Framework – Guidance Update
Established Medicines Application Process Changes MHRA has updated the guidance on process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products. The guidance has been amended to detail changes in application process. Established Medicines Application Process Changes
