A report from the EMA/FDA QbD pilot program concluded that, on the basis of the applications submitted for the pilot, there is solid alignment between both agencies regarding the implementation of multiple ICH Q8, Q9 and Q10 concepts. The program opened up a platform for continuous dialogue. The agencies are currently exploring potential joint activities with specific focus on continuous manufacturing, additional emerging technologies, and expedited/accelerated assessments (e.g., PRIME, Breakthrough). Additionally, EMA and FDA are hosting experts from each other’s organizations to facilitate dialog and explore further opportunities.
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