FDA / EMA Common Commentary on Submitting an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP) for the Prevention and Treatment of COVID-19

Given the global public health crisis resulting from the coronavirus disease 2019 (COVID-19) pandemic, FDA and EMA are providing procedural assistance to sponsors and applicants who anticipate submission of pediatric product development plans for new drugs and biological products for the treatment or prevention of COVID-19. FDA and EMA are issuing this Common Commentary to streamline administrative processes and facilitate efficient submission of an iPSP and PIP. This Common Commentary addresses only the submission of an iPSP and PIP for a drug or biological product for treatment or prevention of COVID-19.

Given the need to generate clinical trial data to inform safe and effective use of products to treat and prevent COVID-19 in pediatric patients, FDA and EMA encourage early submission of an iPSP and PIP. Furthermore, FDA and EMA meet as needed to exchange information to facilitate product development for the pediatric population.