www.ema.europa.eu The aim is to guide non-commercial developers of promising ATMPs addressing unmet medical needs through the regulatory and scientific requirements in the European Union (EU) and better understand their needs to enable them to advance the development of their medicines and...

www.ema.europa.eu All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025. This date marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU....

www.ema.europa.eu On 24 January 2024, the CMDh1 endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines. These measures are to address a potential increased risk of neurodevelopmental disorders in children born...

www.ema.europa.eu Three new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.The committee recommended granting a marketing authorisation for Exblifep (cefepime/enmetazobactam), for the treatment of...

www.ema.europa.eu This medicine is used for treating patients with Duchenne muscular dystrophy whose disease is caused by a type of genetic defect called a ‘nonsense mutation’ in the dystrophin gene and who are able to walk. The initial recommendation followed the full re-evaluation of...

www.ema.europa.eu EMA has published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.In 2023, EMA recommended 14 medicines for marketing authorisation. Of these, nine had a new active substance - a threefold increase...