Analysis

Of all 68 applications evaluated by the EMA Committee for Medicinal Products for Human use (CHMP), 45 (66%) were approved, whereas 23 (34%) were not; 6 received a negative opinion and 17 were voluntarily withdrawn by the applicant before a final opinion was made by the CHMP. The summary scores in the three categories — development plan, clinical outcome and clinical relevance — are shown in Table 1, stratified for approved and non-approved applications. All eight drugs with a positive rating for the development plan, a positive clinical outcome and convincing clinical relevance were approved, whereas 12 out of 14 applications for which all three scores were negative were not approved.

Table 1 Summary scorecard of EMA assessment of 68 MAAs*
Full size table

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