A-pharmaconsult sas’ Post

#MedSafetyWeek 💊⚕ 📌#EveryReportCounts - Report Medicine Side Effect or Suspected Adverse Drug Reactions. Help make medicines safer for everyone. Tell your medical professional about the side effect or report to the medicines regulatory for your region on the Island of Ireland. By doing so, it will help make drug/medication use safer for everyone. Report suspected side effects from medicines, including new treatments or medicines that have been taken a long time. In Rep of Ireland, it is reported to Health Products Regulator Authority (HPRA). https://lnkd.in/ewzXxA3S In Northern Ireland it is reported to the Medicines & Healthcare Regulatory Agency (MHRA) https://lnkd.in/epenmwAm #MedSafetyWeek2024 #MedicationSideEffects

📢 The European Shortages Monitoring Platform (#ESMP) is live! The platform is now available to marketing authorisation holders, who will be able to submit data on shortages of centrally authorised human medicines in the ESMP. ESMP is an important regulatory tool that will: 🔸 gather comprehensive information on the availability, supply and demand of human medicines 🔸 help to detect, prevent and manage shortages in the EU and the EEA 🔸 facilitate communication between EMA, national competent authorities and industry to ensure medicines are available for those who need them.   Learn more about what’s next for ESMP from our news announcement (link in comments). #publichealth #shortages #medicines #healthunion

One step to get visibility on medicines shortages. The European Medicines Agency took a non-siloed approach in the building of the platform. Setting this up for pharma still represents an effort to link the depth of the regulatory data, enriched with supply chain (CDMO, ingredients suppliers) with the shortage information. Preparing is not a marginal task, and deciding on a fully automated process vs. manual activity can be impacting. How is pharma geared up to be able to transmit information to ESMP? #medicinesshortages #ESMP Aditi Karnad Anelia Boshnakova Marco Torciani

📢 The European Shortages Monitoring Platform (#ESMP) is live! The platform is now available to marketing authorisation holders, who will be able to submit data on shortages of centrally authorised human medicines in the ESMP. ESMP is an important regulatory tool that will: 🔸 Gather comprehensive information on the availability, supply and demand of human medicines 🔸 Help to detect, prevent and manage shortages in the EU and the EEA 🔸 Facilitate communication between EMA, national competent authorities and industry to ensure medicines are available for those who need them. Learn more about what’s next for ESMP from EMA news announcement (https://lnkd.in/gNaHAQ89). #publichealth #shortages #medicines #healthunion

🚨 New Variation Regulation: Are You Prepared? 🚨 Starting January 1, 2025, the amended Variations Regulation (EU) 2024/1701 will come into effect, introducing streamlined processes for post-authorisation changes to marketing authorisations. This marks a significant step forward in simplifying the lifecycle management of medicinal products for human use. 🔑 What’s changing? • Updated Article 5 procedures. • Annual updates for Type IA minor variations. • New rules for grouping and super-grouping Type IA variations. • Mandatory worksharing procedures to improve efficiency. 🛠️ What should you do now? During the transition period, marketing authorisation holders (MAHs) must continue following the current guidelines until the updated version is published. Take this time to review your systems, documentation, and processes to ensure a seamless transition. 📢 Stay up to date by checking the CMDh and EMA websites regularly : https://lnkd.in/eeEF9RJi #PharmaRegulations #EUCompliance #Medicines #MarketingAuthorisation #Healthcare

The European Shortages Monitoring Platform (#ESMP) is now live. Since data are drawn from PMS (populated by SIAMED and XEVMPD), this is a significant driver for SPOR and IDMP in general.

In recent years, regulatory agencies have developed risk-based approaches for the assessment of marketing authorisations of new active substances (NASs) as strategies to efficiently use limited resources and accelerate the availability of innovative therapies to their populations. In this study, which was presented as a poster at #DIA2024, CIRS analysed the use of the following risk-based approaches for the approval of NASs by FDA, Health Canada, Swissmedic and TGA: 👉 Unilateral reliance 👐 Collaboration (#ProjectOrbis) 🤝 Work sharing (#AccessConsortium) The results showed that the usage of risk-based approaches lead to shorter regulatory timeline metrics, such as submission gap and approval time for the marketing authorisation of NASs. CIRS will be updating this analysis in its next regulatory R&D Briefing – so keep an eye out for this on our LinkedIn page 👀 or you can sign up to our mailing list to be alerted directly 📢 Sign up to the CIRS mailing list >> https://lnkd.in/eREqpwCF

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) expects the new UK clinical trial regulation to be implemented by January 2026. Learn more here: https://ow.ly/6iYj30sI4vn

Health Canada, the U.S. Food and Drug Administration (FDA), and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly issued Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles. Devices enabled with machine learning are able to learn using real data without being manually programmed. This document follows upon our previous joint publication on guiding principles for good practices in machine learning and provides important considerations in developing good transparency practices. Good transparency practices can promote informed decision-making, provide clear and accurate information about a machine learning-enabled medical device and its performance, and encourage increased trust and adoption of beneficial technologies. For more information: https://ow.ly/nBPc50SigZb

MHRA: Guidance for Manufacturers Following Revised Brexit Deal The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance for wholesalers and manufacturers in response to the Windsor Framework, which updated the terms of Brexit. The Windsor Framework establishes long-term provisions for the supply of medicines to Northern Ireland, shifting some regulatory powers. MHRA will now regain the authority to license medicines across the UK, and the EU Falsified Medicines Directive safety features will no longer apply to products in Northern Ireland. These changes will take effect at the beginning of next year. >>> read more: https://lnkd.in/efETWDVm #gmpnews #gmp #mhra #brexit #windsorframework