Regulation (EC) 1901/2006 is clear that paediatric investigation plans (PIPs) apply to children from birth to 18 years of age, which omits the unborn foetus. To understand whether any recommendations exist which would support seeking agreement on a PIP for this special population, a review of European legislation, guidelines and other application precedents was undertaken. This article summarises the review and provides insight into distinctions that may be made by the agency in this matter, as well as highlighting relevant precedents which were identified during the review.

While PIPs are not required for foetal medicines, the Paediatric Development Committee (PDCO) appears willing to consider them. Filing a PIP could help de-risk development and represents a valuable opportunity to gauge whether the proposed clinical development plan meets other established requirements.