EMA starts the publication of data concerning the clinical studies according to the Clinical Trial Transparency

EMA recently published a press release on Clinical Trial Transparency . The text informs that, as of October 20, the Agency started the publication of the redacted clinical reports* of drugs with MAA submitted on or after January 1, 2015, * (or July 1, 201, for extensions/modifications of Indication /line extensions).**
The website https://clinicaldata.ema.europa.eu publishes today the documents concerning Kyprolis (Amgen) and Zurampic (Grunenthal). The Agency seems to have an ambitious program to load 4500 clinical reports per year.

*Mod 2.5, 2.7, 5 of the CTD, plus appendices 16.1.1, 16.1.2 and 16.1.9 as defined in the ICH E3 document.
**The date of entry into force of the EMA Policy 0070 on the publication of clinical data for human medicines.