Module232025

Module 23 reading material

Here is some recommended reading for Module 23

Legal Framework

EU

 Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use;  Regulation (EC) No 1902/2006, an amending regulation in which changes to the original text were introduced relating to decision procedures for the European Commission  Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use  European Commission: 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 (2014/C 338/01)

USA 

Best Pharmaceuticals for Children Act (BPCA)  Pediatric Research Equity Act (PREA)  Title V of FDA Safety and Innovation Act (FDASIA)

UK

 The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Guidance

ICH The ICH guidelines are a great starting place when it comes to paediatric drug development considerations. In particular, focus on:

E11(R1) Clinical Investigation of Medicinal Products in the Pediatric Population: Guideline and Addendum

E11A EWG Paediatric Extrapolation

M15 General Principles for Model-Informed Drug Development

M3(R2) Non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals