CCI stands for Commercially Confidential Information. In the context of Policy 70, CCI refers to any information included in the clinical reports submitted to the European Medicines Agency (EMA) by the applicant or Marketing Authorization Holder (MAH) that is not publicly available and whose disclosure could potentially undermine the legitimate economic interests of the applicant/MAH.
CCI is a critical aspect of regulatory processes, particularly when it comes to transparency in clinical trial data. Striking the right balance between transparency and the protection of sensitive commercial information is essential for fostering trust, encouraging innovation, and promoting access to important medical research and information.
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