23 April 2026 - The trend for the timing of initial marketing authorisation applications to be less predictable is slowly reversing but there remains room for improvement, the EMA said.

EMA and industry representatives formed a focus group to look at submission predictability in 2022. By then, the recurrent problem of unreliable long-term planning for initial marketing authorisation applications for centralised procedures had become unsustainable because the pandemic had stressed regulatory resources. The focus group’s initial report found actions taken in 2023 failed to significantly improve submission predictability.

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