Regulatory information - Paediatric guidance revised to reflect changes to European Commission guideline
NewsHumanRegulatory and procedural guidancePaediatrics
Documents relate to submission of applications, re-examination and compliance check procedures
The European Medicines Agency has published revised documentation related to paediatric investigation plans (PIPs) to reflect recent changes to the European Commission's guideline on PIPs.The guidance documents relate to the procedures for submission of PIP/waiver applications, Re-examination procedure of paediatric investigation plan and / or waiver opinions by the PDCO and Questions and answers on the procedure of paediatric-investigation-plan compliance verification at the European Medicines Agency, and paediatric rewards.
The revised documents take into account the changes and simplifications that have been introduced by the European Commission in the recently published guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies.