European Medicines Agency reminds marketing-authorisation holders about requirement for paediatric annual reports
The European Medicines Agency reminds marketing-authorisation holders that have received a deferral on a paediatric investigation plan (PIP) that they need to submit an annual report to the Agency. These reports should provide an update on progress with the studies included in the PIP.
The obligation to provide annual reports is defined in Article 34(4) of the Paediatric Regulation.
The Agency is currently compiling a list of marketing-authorisation holders that fail to submit their annual reports by the due date. It will forward this list to the European Commission and publish it on this website in the near future.
A PIP is a development plan aimed at ensuring that the necessary data are obtained through studies in children, when it is safe to do so, to support the authorisation of a medicine for children. They are agreed between the company developing a medicine and the Agency's Paediatric Committee (PDCO).
The PDCO can agree to a deferral of studies described in PIPs until after studies in adults have been conducted. The purpose of these deferrals is to make sure that research in children is done only when it is safe and ethical to do so.