In October 2014, the EMA adopted Policy 0070 on publication of clinical data for medicinal products for human use. 

The aim of the Policy 0070 is to make clinical data as submitted as part of a centralized procedure, publicly available. In theory, data should be submitted as a proposed redacted and final redacted version during the Centralised Procedure (between day 180-220).

However, the EMA has acknowledged that for both sides, the initial operational implementation of Policy 0070 is a learning process.

To read more, please download this whitepaper. 

EXTEDO is committed to follow the highest standards on Data Protection.

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