EMA WELCOMES PUBLICATION OF NEW CLINICAL TRIALS REGULATION
June 8th, 2014THE EUROPEAN Medicines Agency (EMA) has welcomed the publication of the European Union’s new clinical trials regulation in the EU Official Journal. Whilst authorisation and oversight remains an EU member state responsibility, the new legislation mandates EMA to prepare IT systems to help sponsors and experts authorise and supervise clinical trials, ensuring safety reporting and enhanced information access. *http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2014:158:FULL&from=EN
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