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  • 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 ...
  • Regulatory NewsRegulatory News

    EU’s Pediatric Regulation: European Commission Seeks Feedback for New Report

    The European Commission (EC) on Tuesday launched a public consultation to obtain feedback for its second report on the  Pediatric Regulation,  ten years after its implementation. The comments on the consultation, which is open until 20 February 2017, will help inform the EC's report, which is expected to be published in 2017 and will assess the regulation's impact on public health and the pharmaceutical industry. Background The Pediatric Regulation, known in the EU ...
  • Regulatory NewsRegulatory News

    EMA Announces Sweeping Overhaul of Pediatric Class Waivers

    In a major move, the European Medicines Agency (EMA) announced today it is revoking or revising most product class waivers that allow companies to bypass the requirement to test new drugs in pediatric populations before they can be authorized. Background Companies are often reluctant to conduct clinical studies in children over ethical concerns and fear of adverse events occurring during trials. These reservations have created a gap in the number of products authorized ...
  • Regulatory NewsRegulatory News

    EMA Hopes Early Dialogue With Drugmakers Will Spur Pediatric Drug Development

    The European Medicines Agency (EMA) is piloting a new initiative to offer early meetings with companies to foster discussions about their pediatric development strategies for new medicines. Background Companies are often reluctant to conduct clinical studies in children due to ethical concerns and fear of adverse events during trials. However, conducting clinical research on children is critical to determining whether drugs are safe and effective in pediatric population...
  • Regulatory NewsRegulatory News

    Bioethics Council Calls for Reforms for Clinical Trials Involving Children

    The Nuffield Council on Bioethics has released a report on the ethical issues surrounding clinical research involving children in the UK and EU. The report, which looks at the current status of clinical research and regulations, argues better regulation and greater involvement from children is critical to increasing the number of clinical trials involving children. Background Companies are often reluctant to conduct clinical studies on children due to ethical concerns ...
  • Regulatory NewsRegulatory News

    EMA, FDA Team Up to Propose Guideline on Pediatric Gaucher Disease

    US and EU regulators have come together to release an unusual joint proposal that they say will help speed up the development of new treatments affecting pediatric patients with Gaucher disease. Background Gaucher disease is a rare, inherited lysosomal storage disorder which affects patients by causing the buildup of lipids in cells and organs, such as the liver, spleen, kidneys and brain. It is thought that about 20,000 patients have Type I Gaucher disease in the US, a...
  • European Commission Releases First Report on the Pediatric Regulation

    The European Commission today published a progress report on medicines for children covering the five years since the Pediatric Regulation came into force. Although it will take several more years to fully assess the impact of the legislation due to long drug development cycles, this preliminary review points to significant improvements in the pediatric medicines landscape: better and safer research, more products for children on the EU market and more information for p...
  • EMA Releases Revised Draft Guideline on Pediatric Regulation

    The European Medicines Agency (EMA) has released a newly-revised draft guideline regarding the development of pharmaceutical products intended for use in children, taking into account comments received on a draft version released in 2011. The changes made to the initial draft guideline, Guideline on pharmaceutical development of medicines for paediatric use , were reportedly significant enough for EMA to partially restart the comment period on the guideline, which i...
  • European Commission Issues Draft Pediatric Regulation Report

    The European Commission is requesting public comment on its draft report to the European Parliament on the five years of experience since the Pediatric Regulation entered into force in January 2007.  The Regulation was adopted in response to a lack of suitable, authorized medicinal products for children in the EU. Studies had shown that over 50% of the medicines used for children might not have been tested in pediatric populations, leaving providers not choice bu...
  • 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 ...
  • MHRA Rolls Out First-ever Information Leaflet Specifically Aimed at Children

    Some medicines approved to treat attention deficit hyperactivity disorder (ADHD) in the UK will soon include information in the patient information leaflet specifically targeted towards those under the age of 18 thanks to a partnership between regulators, academia and industry. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced Thursday, 7 June it is moving to implement the new information layout-reportedly the first time it has been done in th...
  • European Ombudsman Chides EMA for Transparency Problems

    A report from the European Ombudsman calls on the European Medicines Agency (EMA) to increase the transparency surrounding its pediatric medicines testing requirements after finding an inconsistent application of regulations and a lack of disclosure from the agency. The inquiry was launched after two pharmaceutical companies-kept anonymous in the complaint, but reportedly Takeda and AstraZeneca -complained they were subject to an unfair application of EMA's 2006 Paediat...