Implementation of the Paediatric Regulation: new Commission Guideline

"A Commission guideline implementing certain provisions of Regulation (EC) No 1901/2006 (the paediatric regulation) has been published on 24 September. Pursuant to Article 10 of the Regulation, this guideline provides the detailed arrangements concerning the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers and deferrals. The guideline also lays down the arrangements for the operation of the compliance check referred to in Articles 23 and 28(3) of the Regulation. Finally, pursuant to Article 45(4), the guideline provides the assessment criteria for the significance of studies started before and completed after the entry into force of the paediatric regulation."

Source: European Commission, Pharmaceuticals, News

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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