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We compared the review times of medicines licensed by the 2 agencies and explored differences in the evidence submitted In 2015–2017 the FDA licensed 113 drugs, 66 of which reached Europe The median review time was longer at the EMA than FDA and was shorter for drugs undergoing FDA‐expedited programmes compared to the same drugs approved pubmed ncbi nlm nih gov 31657044--- ema europa eu en ema-statement-ongoing-review-glp-1-receptor-agonistsThe review process Companies wishing to market a medicinal product that is eligible for the centralised authorisation procedure, submit their application directly to the European Medicines Agency (EMA) The EMA is responsible for the validation and scientific evaluation of the application The high prices of new anticancer drugs and the marginal added benefit perceived by some stakeholders have fuelled a debate on the value of anticancer drugs in the European Union, even though an New psychoactive substances (NPS) continue to appear in Europe at the rate of one per week, posing a public health challenge In 2021, 52 new drugs were reported for the first time through the EU Early Warning System Contact: Kathy Robertson, Media relations Praça Europa 1, Cais do Sodré, 1249-289 Lisbon, Portugal Tel (351) 211 21 02 00 I The evaluation of medicines, step-by-step The assessment of a marketing authorisation application for a new medicine takes up to 210 ‘active’ days This active evaluation time is the time spent by EMA experts to evaluate the evidence provided by the applicant in support of a marketing authorisation application This time is interrupted by --- emcdda europa eu system files Highlights_EDR2022_EN_Finalweb_REV2 pdfThe European Medicines Agency (EMA) facilitates development and access to medicines for countries within the European Union (EU) EMA evaluates applications for marketing authorisation submitted via the centralised procedure, monitors the safety of medicines across their lifecycle and provides information to healthcare professionals and patients --- ncbi nlm nih gov pmc articles PMC6983504--- emcdda europa eu edr2021_en--- ema europa eu en evaluation-medicines-step-step--- ema europa eu en medicines11 July 2023 News Human EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 receptor agonists, 1 including Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide) These medicines are used for weight loss and for treating type 2 diabetes --- nature com articles s41571-021-00584-zStatistical Bulletin 2021 The annual Statistical Bulletin contains the most recent available data on the drug situation in Europe provided by the Member States These datasets underpin the analysis presented in the European Drug Report All data may be viewed interactively on screen and downloaded in Excel format Access >> The European Drug Report 2023: Trends and Developments presents the EMCDDA’s latest analysis of the drug situation in Europe Focusing on illicit drug use, related harms and drug supply, the report contains a comprehensive set of national data across these themes and key harm reduction interventions health ec europa eu authorisation-procedures-centralised-procedure_enThe Food and Drug Administration (FDA) and European Medicines Agency (EMA) now have expedited review procedures for new drugs We compared the review times of medicines licensed by the 2 agencies and explored differences in the evidence submitted In 2015-2017 the FDA licensed 113 drugs, 66 of which …--- emcdda europa eu publications european-drug-report 2023_en
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