In Europe, advanced therapy medicinal products (ATMPs) are subject to the requirements laid down in the Paediatric Regulation. A company developing an ATMP must, therefore, obtain agreement from the EMA on a paediatric investigation plan (PIP) or waiver prior to submitting its marketing authorisation application (MAA).
David Uguen, Cecile de Coster
Considerations on paediatric investigation plans for advanced therapy medicinal products, TOPRA Vol 8, No.10
2011 – Regulatory Rapporteur
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