Regulatory and health technology assessment advice on post‐licensing and post‐launch evidence generation is a foundation for lifecycle data collection for medicines

Br J Clin Pharmacol

11 March 2020 - The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. 

There may be uncertainties associated with the new medicinal product that cannot be, or do not need to be resolved before launch.

Post‐licensing or post‐launch evidence generation is a term for evidence generated after the licensure or launch of a medicinal product to address these remaining uncertainties.

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Michael Wonder

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Michael Wonder