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European Medicines
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Rare diseases, orphan medicines - European Medicines …
www.ema.europa.euRare diseases, orphan medicines . Getting the facts straight . EMA is eager for European citizens with rare diseases to have accessto specific and effective medicines. The European Union’s orphan legislation has been designedto help overcome the extra hurdles these medicines face to get on the market.
European Medicines Agency policy on publication of ...
www.ema.europa.euEuropean Medicines Agency policy on publication of clinical data for medicinal products for human use EMA/144064/2019 Page 5/22 • Protecting the Agency's and the European Commission's deliberations and decision-making process: Regulators have a legal mandate to evaluate medicines. In doing so, they should only focus on the