Regulation (EC) No 1901/2006: EU paediatric medicines

European Union, regulation. Regulation (EC) No 1901/2006 on medicinal products for paediatric use entered into force on 26 January 2007 and created the Paediatric Committee (PDCO) at the European Medicines Agency. Primary text: EUR-Lex.

What it requires and rewards: an applicant for a new medicine, or a new indication, form or route for a patented one, must submit a paediatric investigation plan (PIP) at the end of phase 1 and agree it with the PDCO, unless the plan is deferred or the condition does not occur in children (a waiver). Completing the plan earns a six-month extension of the supplementary protection certificate, or two extra years of market exclusivity for an orphan medicine. A paediatric-use marketing authorisation (PUMA) rewards developing off-patent medicines for children.

Why oncology argued about it: because childhood cancers are different diseases from adult ones, the regulation's condition-based logic allowed 'class waivers' for adult-only cancers, so a lung or breast cancer drug with a target shared by paediatric tumours could avoid paediatric study, the same gap the United States closed with the RACE for Children Act in 2017. The EMA revised the class waiver list in 2015, the Commission's 2017 report acknowledged the problem, and the 2023 pharmaceutical package proposes requiring a PIP whenever the medicine's mechanism of action is relevant to a paediatric disease. The ACCELERATE platform brings regulators, academics, companies and parents together to decide which paediatric plans matter most.