REJECTED MA APPLICATIONS:

A rejected marketing authorization application is painful for a company in many ways: a significant amount of invested money may go to waste, product market launch may be stopped or delayed, and doubt may be shed on the R&D- and Regulatory strategy of the company.

Question: what are the most common causes of rejected MA applications?

Method: MAx analysed all rejected MA applications for pharmaceuticals in the EU MRP/DCP procedures in the period 2014 – 2024. The reasons for rejection was possible to identify for 26 medicinal products for which the assessment report was published (source: MRI index)

Results: we found 22 clinical data insufficiencies that were part of grounds for rejection. By far the most common problem was difficulties in demonstrating bioequivalence (BE) with a reference product. This reflects the fact that the MRP/DCP procedure is used by many generic companies and showing BE is a key requirement for obtaining a marketing authorization.

We found 19 quality data insufficiencies that were part of grounds for rejection. The problems in the quality area were more diverse and included problems with QP declaration, dissolution limits, stability and nitrosamine testing.

Conclusion: the single most problematic area for applicants in MRP/DCP appears to be demonstration of bioequivalence.

Disclaimer: this analysis only included data from published assessment reports.

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