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www.ema.europa.eu EMA is advising marketing authorisation holders to submit individual type IA and type IAIN variations and super-groupings for 2025 no later than 21 November 2025. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 23...
www.ema.europa.eu EMA has published a draft reflection paper on patient experience data for public consultation. These are data directly reflecting patients’ experience or preferences on treatments or outcomes, without any interpretation by a clinician or anyone else.Patients’ perspectives...
www.ema.europa.eu EMA’s Patients and Consumer Working Party (PCWP) has elected Marco Greco of the European Patients Forum as its new co-chair. The Healthcare Professionals’ Working Party (HCPWP)…, Marco Greco is a lawyer by training and has extensive advocacy experience. He is a...
www.ema.europa.eu The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have jointly developed two new targets for clinical trials, to monitor progress against the ambition to make the European Union (EU) a more attractive destination for clinical research and improve...
www.ema.europa.eu As included in the product information for paracetamol in the EU, a large amount of data from pregnant women who used paracetamol during pregnancy indicates no risk of malformations in the developing foetus or in newborns.In 2019, EMA reviewed available studies that...
www.ema.europa.eu EMA welcomes the publication of the European Commission’s (EC) new Variations Guidelines, which streamline the lifecycle management of medicines (see EC news). These guidelines will support the implementation of the new Variations Regulation that came into force in January...