Selected Publications

A Fresh Perspective on Comparing the FDA and the CHMP/EMA: Approval of antineoplastic tyrosine kinase inhibitors

Shah RR, Roberts SA, Shah DR.


Rashmi Shah Consultancy Ltd, Gerrards Cross, UK.


We compared, and determined the reasons for any differences in, the review and approval times of tyrosine kinase inhibitors (TKI) by the FDA and the EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to 6 (38%) and CHMP granted (the equivalent) conditional approvals to 4 (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared to 409.6 days in the EU. The active 225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20-days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review times, however were comparable (review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents, and societal expectations.