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clinicaldata ema europa eu web cdp homeAdditionally, EU legislation provides for common rules for the conduct of clinical trials (to test the safety and efficacy of medicines under controlled conditions) in the EU Various rules have also been adopted to address the particularities of certain types of medicinal products and promote research in specific areas:en wikipedia org wiki European_Medicines_AgencyThe clinical data refer to Loargys (pegzilarginase), an orphan medicine indicated for the treatment of arginase 1 deficiency (ARG1 D) - also known as hyperargininemia - in adults, adolescents and children aged two and older More information on Loargys is available on EMA's corporate website 21 03 2024: Clinical data published --- nature com articles d41573-020-00032-0Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA) [4] [5] The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry , as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory --- ema europa eu en homepageThe European Medicines Agency's (EMA) office is closed from 18:30 on Wednesday 27 March 2024 to 07:30 on Tuesday 2 April 2024 Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31 (0)88 781 7600 26 March 2024 --- europarl europa eu health-union-a-stronger-role-for-the-european-medi EMA is a decentralised agency that evaluates and monitors medicines for humans and animals in the EU and the EEA It issues marketing authorisations, provides safety information, and supports research and development of new medicines After 3 years of co-design with stakeholders and EU regulatory partners, the European Medicines Agency’s Regulatory Science to 2025 strategy has been finalized Here, we highlight the core european-union europa eu european-medicines-agency-ema_enhealth ec europa eu legal-framework-governing-medicinal-products-human-us Health Union: a stronger role for the European Medicines Agency The EU will be better prepared to manage future health crises by tackling shortages of medicines and medical devices more effectively Parliament endorsed the provisional agreement reached with the Council last year on increasing the powers of the EU’s medicines regulator with
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