EMA Transparency Policy 0070, on the publication of Clinical Data, has been reinstated by EMA this year for new active substances registered under the centralized procedure, becoming effective from this September.
The publication of Clinical Data must follow strategies and techniques defined by the EMA, in order to assure the balance between the protection of personal data whilst maintaining the maximum data utility.
Asphalion experts Ivette Camarasa and Nuria García Pazos review the latest updates on the policy, timelines, CCI challenges and pre-submission meeting recommendations.
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