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The number of new molecular entities approved in the US each year has declined from 36 to 18 since 2004 [link widoczny dla zalogowanych], despite a sustained increase in the amount of clinical trials conducted.

Biosimilar approval structures in the EMEA are significantly more comprehensive than those of the FDA. Europe is now becoming the global center for biosimilar development and production.
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The EMEA is approving fewer products than the FDA even though processing speed and volume have been significantly improved. System reforms include reduced review times, faster approvals for innovative drugs and relaxed requirements in pediatric trials.
The FDA and EMEA are asking for more data in drug applications that pose heightened safety concerns, although there have been no official changes in overall drug approval standards.

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Drug Approval Trends at the FDA and EMEA: Process improvements, heightened scrutiny and industry response
Business Intelligence for the Pharmaceutical Industry
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Some key findings from this />
Information about new drug candidates is being increasingly shared by the FDA and EMEA as globalization continues throughout the pharma industry. Such convergence is prominent in the orphan drugs area, where evaluations require considerable resources.