MHRA Windsor Framework Industry Webinar October 2024 MHRA is running a webinar on the Windsor Framework for medicines on Wednesday 23 October 2024 between 2.30 - 4pm. This is the second in a series of two webinars, and will focus on a range of published guidance. MHRA Windsor Framework Industry Webinar October 2024
DSIT Announce New Regulatory Innovation Office The Department of Science, Innovation, and Technology (DSIT) has announced the launch of the new Regulatory Innovation Office (RIO). The RIO’s primary goal is to reduce red tape and accelerate public access to emerging technologies, supporting economic growth in the process. DSIT Announce New Regulatory Innovation Office
MHRA Windsor Framework Industry Webinar Recording MHRA has published the recording of the MHRA Windsor Framework Industry Webinar, which took place on 19 September 2024, and which was in preparation for the Windsor Framework implementation date. MHRA Windsor Framework Industry Webinar Recording
PAGB Webinar: Hot Topics in Herbal Medicines and Botanical Supplements – An update on what is Happening in the UK and EU PAGB is running a webinar for members, 'Hot topics in herbal medicines and botanical supplements – an update on what is happening in the UK and EU', on Wednesday 13 November from 1 - 2pm. PAGB Webinar: Hot Topics in Herbal Medicines and Botanical Supplements – An update on what is Happening in the UK and EU
MHRA Established Medicines Webinar MHRA is running a webinar on established medicines on Thursday 17 October between 10 – 11am. The webinar will outline the latest updates on the MHRA Marketing Authorisation applications for established medicines and current performance. MHRA Established Medicines Webinar
EMA New Fee Regulation Webinar EMA is hosting a webinar titled ‘New fee regulation: webinar for Industry stakeholders’ to outline the main changes brought by Regulation (EU) 2024/568. EMA New Fee Regulation Webinar
EMA Management Board – October 2024 Meeting Highlights The EMA has published the highlights of the EMA Management Board meeting that took place on 4 October 2024. EMA Management Board – October 2024 Meeting Highlights
EMA Reflection Paper on use of AI in Lifecycle of Medicines The European Medicines Agency (EMA) has published a reflection paper on the use of artificial intelligence in the lifecycle of medicines. EMA Reflection Paper on use of AI in Lifecycle of Medicines
MHRA – Updated Guidance on Pre-submission Advice & Support The MHRA has updated its guidance on pre-submission advice for medicines Marketing Authorisation applications. MHRA – Updated Guidance on Pre-submission Advice & Support
MHRA Webinar – Implementing the New UK Clinical Trials Regulations MHRA and the Health Research Authority (HRA) are hosting a short webinar on Tuesday 15 October from 2pm – 4pm to introduce their joint plans to share draft guidance with stakeholders and to set out the anticipated timelines for implementing the new UK Clinical Trials regulations. MHRA Webinar – Implementing the New UK Clinical Trials Regulations
MHRA Table of Approved Reclassifications Updated MHRA has updated the table of approved reclassifications 1991 to 2024, which contains the information on UK medicines reclassified from Prescription Only medicine (POM) to Pharmacy (P) medicine, and P medicine to General Sales List (GSL) medicine. The table now contains information up to 30 September 2024. MHRA Table of Approved Reclassifications Updated
MHRA Control Testing Guidance Updates Published MHRA has published updates to the following control testing guidance to reflect the requirements of the Windsor Framework. MHRA Control Testing Guidance Updates Published
