• Regulatory NewsRegulatory News

    EMA’s Pediatric Committee Seeks to Tweak ICH Q&A on Nonclinical Evaluation of Cancer Drugs

    The European Medicines Agency’s (EMA) Pediatric Committee has offered a couple of comments, slight tweaks and further suggestions for the International Council for Harmonisation’s (ICH) draft question and answer document on its S9 guideline on the nonclinical evaluation for anticancer pharmaceuticals. The committee points to a couple of references in the Q&A on S9 on the scope of the guideline and the statement that "the need for juvenile toxicity testing sho...
  • Feature ArticlesFeature Articles

    A Summary of 10 Years of Paediatric Legislation in the European Union

    This article summarizes 10 years of experience with paediatric regulations in the EU. Introduction Almost 10 years ago, on 27 January 2007, new Paediatric Legislation (PL) came into force that reshaped the regulatory landscape for paediatric medicines in Europe. 1, 2 The objective of this Paediatric Regulation (PR) is to improve the health of children in the European Union (EU) by: facilitating the development and availability of medicines for children from birth ...
  • EMA Opens Consultation on Proposed Pediatric Development Framework

    The European Medicines Agency (EMA) is opening a public consultation on a newly released report in which it calls for a new framework to incorporate the views of children into the review of clinical trial plans before the Pediatric Committee (PDCO). The report, " Concept paper on the involvement of children and young people at the PDCO ," is aimed at meeting the requirements of the Charter of Fundamental Rights of the EU, which states that member states should take into ...