The Spanish Ministry of Health has published a draft Royal Decree on Clinical Trials, which the Spanish government is expected to adopt by the end of this year. Once adopted, the new Royal Decree will replace Royal Decree 223/2004 on Clinical Trials and will regulate all clinical trials with medicines and medical devices in Spain.
Among other changes, the draft Royal Decree would introduce the following:
- Spanish Clinical Trials Register: the draft Royal Decree would establish a Spanish Clinical Trials Register publicly accessible on the website of the Spanish Medicines Agency.
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