European Medicines Agency’s Post

Fantastic to see this important work being shared more widely - please do read the full post to see how great this collaboration is, including taking onboard feedback from industry to simplify the process. 👏 #international #collaboration #regulatoryaffairs #dialogue

Transformational regulatory reliance work is happening in the best interest of patients everywhere.

📝 An estimated 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified, according to new research from #WHO. This means that people are taking medicines that fail to treat or prevent disease. This means that people are taking medicines that fail to treat or prevent disease. Not only is this a waste of money for individuals and health systems that purchase these products, but substandard or falsified medical products can cause serious illness or even death. “Substandard and falsified medicines particularly affect the most vulnerable communities,” says Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Imagine a mother who gives up food or other basic needs to pay for her child’s treatment, unaware that the medicines are substandard or falsified, and then that treatment causes her child to die. This is unacceptable. Countries have agreed on measures at the global level – it is time to translate them into tangible action.” Since 2013, WHO has received 1500 reports of cases of substandard or falsified products. Of these, #antimalarials and antibiotics are the most commonly reported. Most of the reports (42%) come from the WHO African Region, 21% from the WHO Region of the #Americas, and 21% from the WHO European Region. This is likely just a small fraction of the total problem and many cases may be going unreported. For example, only 8% of reports of substandard or falsified products to WHO came from the WHO Western Pacific Region, 6% from the WHO Eastern Mediterranean Region, and just 2% from the WHO South-East Asia Region. “Many of these products, like antibiotics, are vital for people’s survival and wellbeing,” says Dr Mariângela Simão, Assistant Director-General for Access to #Medicines, Vaccines and #Pharmaceuticals at WHO. “Substandard or falsified medicines not only have a tragic impact on individual patients and their families, but also are a threat to antimicrobial resistance, adding to the worrying trend of medicines losing their power to treat”. Prior to 2013, there was no global reporting of this information. Since WHO established the Global Surveillance and Monitoring System for substandard and falsified products, many countries are now active in reporting suspicious medicines, vaccines and medical devices. WHO has trained 550 regulators from 141 countries to detect and respond to this issue. As more people are trained, more cases are reported to WHO. 📩: [email protected] #TajPharma

First version of the Union list of critical #medicines 💊agreed to help avoid potential #shortages in the #EU 🇪🇺 The European Commission (EC), the Heads of Medicines Agencies (HMA) and #EMA have published the first version of the Union list of critical medicines. It contains more than 200 active substances of medicines for human use considered critical for healthcare systems across the EU/EEA, for which continuity of supply is a priority and shortages should be avoided. The European medicines regulatory network will prioritise critical medicines for EU-wide actions to strengthen their supply chain.

For #medicaldevice manufacturers in the #EU. 🇪🇺 European Medicines Agency #EMA and #HMA published the latest developments from their ongoing efforts to advance the use of Real-World Data #RWD in supporting EU regulatory decisions. Building on the groundwork laid from September 2021 to February 2023, the report covers the period from 8 February 2023 to 7 February 2024, marking the second year of DARWIN EU. The report highlights the strides towards integrating RWE alongside traditional randomized controlled trials in regulatory decisions, in alignment with the European Medicines Regulatory Network (EMRN) and the EMA’s Regulatory Science Strategy to 2025. Key updates include: ✅ Inclusion of all studies conducted by EMA, including those related to vaccine safety, effectiveness, and public health emergencies.  ✅ Detailed review of the three RWE generation pathways: DARWIN EU network, in-house EMA studies, and commissioned research organizations.  ✅ Insights into the use of RWD by national competent authorities (NCA). EMA is committed to establishing a robust framework that will enable better integration of RWD/RWE into the development, authorization, and supervision of medicines by 2025, following the Big Data Task Force's priority recommendations. Contact us for qualified support in ensuring compliance to the regulatory requirements and if you need support around your clinical study design, benchmarking it or do the statistic for its evaluation?☞ [email protected] #HealthcareInnovation #RegulatoryScience #RealWorldEvidence #RWE #EMA #BigData #Pharmacovigilance #DARWINEU #DataDrivenHealthcare #EURegulations #HealthData #HealthTech #Clinicalaffairs #Publichealth #ClinicalTrials #Patientsafety 

Exciting Collaboration for African Healthcare: EMA and AMA Join Forces 🤝 The European Medicines Agency (EMA) has received a generous grant of ten million euros from the European Commission to bolster healthcare in Africa. This funding is a cornerstone in setting up the African Medicines Agency (AMA), a specialized agency of the African Union. 🔍The AMA is set to transform access to quality and safe medical products across Africa. With 27 countries already on board and more joining, AMA aims to harmonize medicine regulation, ensuring faster and safer access to medicines. 💡 EMA’s expertise in regulatory networks will be instrumental in guiding AMA, sharing best practices to improve medicine safety and efficiency. This partnership marks a new era in global health collaboration and patient care. #HealthcareInnovation #GlobalHealth #AfricanMedicinesAgency https://lnkd.in/dgSM6aKf

Two years on, the European Medicines Agency is ramping up capacity of #DARWINEU to generate #realworldevidence to support #regulatory #decisionmaking across #Europe. Read at The Evidence Base® #rwe #rwd #realworlddata #healthdata

EMA / Update of the QRD template - Package leaflet improvement Following its second survey with patients, consumers, and healthcare providers regarding the potential inclusion of a key information section, the European Medicines Agency (EMA) has provided a status update (July 2024) on the review of the package leaflet template and next steps: https://lnkd.in/gu3V7Bum The final proposal of the revised draft template will go for public consultation, tentative date of October 2024. The timings of subsequent next steps will be confirmed at a later date. #EMA #QRD #productinformation #packageleaflet #patientinformation #patientinvolvement #publicconsultation #publicengagement #regulatorycompliance

💊 The European Commission (EC), the Heads of Medicines Agencies (HMA), and EMA have released the first version of the Union list of critical medicines! 💊 This list includes about 200 active substances of medicines for human use that are considered critical for healthcare systems across the EU/EEA. Ensuring continuity of supply and avoiding shortages is of utmost importance. A medicine is classified as critical if it is used to treat serious diseases and cannot be easily substituted in case of shortage. Read more about it: https://lnkd.in/dVcKEFi3

Coming soon World Pharmacists Day, organized by the International Pharmaceutical Federation (FIP), a WHO partner, is a day to recognize and celebrate the crucial role that pharmacists play in building healthier communities everywhere. Pharmacists are integral to our health-care systems, often being the first point of contact for health advice and primary health care, as well as addressing the health needs of our populations in many varied ways, including: ensuring access to and providing guidance on essential medicines and medical devices, including diagnostic tests and assistive products; providing expertise for patient care and public health; promoting disease prevention, such as by administering vaccines, conducting health screening, educating patients, and helping to improve health literacy; supporting public health campaigns; participating in the research and development of new medicines; leading in pharmacovigilance, for instance, ensuring the safety and efficacy of antibiotics and other medicines; implementing greener ways of working and addressing the impacts of environmental factors on health; advocating for policy changes that promote better health outcomes; and as demonstrated during the COVID-19 pandemic, pharmacists are at the forefront of addressing regional and global health crises.