CRED ERP 25

07/07/2025

Figure 2 : MAA Data Exclusivity and Market Protection for Orphan-designated Products

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REAL WORLD EVIDENCE CHALLENGES

The use of RWE in decision making for marketing authorizations depends on many factors, and is summarized in three categories: operational, technical, and methodological.

Essential factors to consider include:

● The information available in the data source, he quality and validity of this information, the design of the data collection, the statistical analytical plan supporting data analysis and interpretation [5].

● In some circumstances, scientific evaluation of the efficacy and safety of medicines prior to granting a marketing authorization may be supported by observational evidence where an RCT is deemed not feasible or unethical [5].

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