Regulation (EC) 1901/2006 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.OJL 378/1, 27.12.2006, as amended by REGULATION (EC) No 1902/2006.

Published by European Parliament and of the Council of the European Union

Medicinal ProductsPaediatric Use 

This Regulation lays down rules concerning the development of medicinal products for human use in order to meet the specific therapeutic needs of the paediatric population, without subjecting the paediatric population to unnecessary clinical or other trials and in compliance with Directive 2001/20/EC.

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ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population. EMA/CPMP/ICH/2711/1999. Step 5. 

Published by European Medicines Agency

Paediatric FormulationPharmacokineticPaediatric Medicinal Product Development

This document describes that paediatric drug development has evolved since the original ICH E11 Guideline (2000), requiring consideration of regulatory and scientific advances relevant to pediatric populations. This addendum does not alter the scope of the original guideline which outlines an approach to the safe, efficient, and ethical study of medicinal products in the pediatric population.

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Ethical considerations for clinical trials on medicinal products conducted with minors. Recommendations of the expert group on clinical trials for the implementation of 12 Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (2017).

Published by EC

NeonateMinorAdolescentConsentAssent Clinical TrialsEthics Committee

The document provides recommendations on various ethical aspects of clinical trials performed in children from birth up to the legal age of adulthood.

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Committee for Medicinal Products for Human Use (CHMP) and Paediatric Committee (PDCO). Guideline on The Investigation of Medicinal Products In The Term And Preterm Neonate. 2009 Doc. Ref. EMEA/536810/2008.

Published by European Medicines Agency

NeonateAdverse EffectsClinical Trials

This guideline addresses the considerations and requirements for the design and conduct of clinical trials in premature and term neonates using medicinal products of relevance for the use by this population. It includes background information on the maturation of organs and of body functions.

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Committee for Medicinal Products for Human Use (CHMP) Role of pharmacokinetics in the development of medicinal products in the paediatric population 2006 Doc. Ref. EMEA/CHMP/EWP/147013/2004.

Published by European Medicines Agency

ExtrapolationDose Finding  AdolescentsNewbornsInfantsToddlersPharmacokineticsChildren

This document provides advice on the use of pharmacokinetic studies in paediatric drug development and on methodological issues concerning pharmacokinetic studies in paediatric patients.

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Joint evaluation of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products.SWD/2020/0163 final

Published by European Commission

Orphan Medicinal Products

Firstly, it assesses the strengths and weaknesses of the two legal instruments, both separately and in combination with each other. It focuses on how they have catered for products for unmet medical needs, taking into account how pharmaceuticals are developed, science advances, and business models change. Secondly, it provides insights into how the various incentives and rewards for which the Regulations provide have been used, along with an analysis of the related financial consequences, both in general and by stakeholder group.

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Preparedness of medicines’ clinical trials in paediatrics. Recommendations by the Enpr-EMA working group on trial preparedness. EMA/56009/2019.

Published by European Medicines Agency

MedicinesClinical TrialsPaediatrics

This document focuses on preparedness for individual trials. However, as a development plan would normally constitute a number of trials, it is implicit that the same elements would also be relevant for preparation of a complete plan. Trial “feasibility” is the likelihood of completing a trial in a timely manner. This document moves beyond the definition of “feasibility” to present a global determination of all aspects of a trial that need to be
prepared.

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UNESCO. International Declaration on Human Genetic Data, 2003.

Published by Unesco

Genetic DataUNESCO

The purpose of the Declaration is to ensure the respect of human dignity and protection ofhuman  rights  and  fundamental  freedoms  in  the  collection, processing, use  and  storage  ofhuman genetic data, in keeping with the requirements of equality, justice and solidarity

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