Module 1 2021

01/07/2021

Learning Outcomes: Recap

• Development of medicines for children is necessary • Paediatric development is mandatory in the EU for new medicines due to the paediatric regulation • PDCO and PIPs; • There are differences in requirements between FDA and EMA, but with joint meetings agreement on specific topics and needs is sought; • Collaboration is essential;

The Organisation for Professionals in Regulatory Affairs

35

literature

• ’t Jong GW. (2002). Unlicensed and off-label drug use in children. Rotterdam: Erasmus Universiteit Rotterdam. • Cuzzolin L, Atzei A, Fanos V. Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf. 2006; 5 :703-18. • Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. • State of Paediatric Medicines in the EU. 10 years of the EU Paediatric Regulation. Report from the Commission to the European Parliament and the Council, 2017. Via www.ema.europe.eu. • How to better apply the Paediatric Regulation to boost development of medicines for children. Report on a multi-stakeholder workshop held at EMA on 20 March 2018. Via www.ema.europe.eu.. • EMA Factsheet: Supporting medicines for children in de EU; http://www.ema.europa.eu/docs/en_GB/document_library/Report/2018/05/WC500249618.pdf • Report of the workshop on paediatric investigation plans in type 2 diabetes mellitus European Medicines Agency, London, 25 February 2013. Via www.ema.europe.eu.. • Reflection paper use extrapolation; https://www.ema.europa.eu/en/documents/scientific-guideline/adopted- reflection-paper-use-extrapolation-development-medicines-paediatrics-revision-1_en.pdf

The Organisation for Professionals in Regulatory Affairs

36

18