Paediatric Research Consultancy

  Helps optimise paediatric trial planning to improve recruitment and compliance

Home Page
  • Benefits of using PRC
  • Service overview
  • Ethos
  • About PRC
  • Short biography
  • Why paediatric trials fail
  • Preventing trial failure
  • Client comments
  • Business etiquette
  • Exclusions
  • Core Services
  • Paediatric info sheets
  • Adult trial info sheets
  • In-house trial training
  • Protocol feasibility
  • PIP feasibility
  • Recruitment/compliance
  • Practical advice
  • Ethical advice
  • Consent/assent advice
  • PRC expert network
  • UK site assistance
  • Information
  • Paediatric clinical trials
  • EU paediatric regulation
  • PIPs
  • Ethical aspects
  • Paediatric info sheets
  • Consent/assent
  • Ethnic considerations
  • Useful publications
  • Useful links
  • Conference diary
    Contact Us
    Text Size
  • Small
  • Medium
  • Large
  • EU paediatric regulation for testing medicines in children

    European Paediatric Medicines Regulation EC 1901/2006

    EU paediatric regulation

    Background: 50% of medicines for children in European hospitals  have not been tested for the children who are given them. Prescribing errors, lack of paediatric formulations  or confusing medication labelling has  resulted in injuries to babies and children, a few of which were fatal. This has led to public and UK parliamentary concern. (House of Commons debate / House of Lords report

    Legal basis: A mandatory regulation (not a more flexible directive) requiring and rewarding companies as appropriate to test medicines on children -  became law across al Member States  26 January 2007.

    Activity: A Paediatric Committee (PDCO) meets regularly at the European Medicines Agency  (EMEA)  in London. It  will assess company Paediatric Investigation Plans (PIPs) provided by pharmaceutical and contract research companies. It is hoped that this Regulation will improve the safety and efficacy of medicines for children.

    Effects on pharmaceutical industry: It will bring tremendous opportunities and challenges for the pharmaceutical industry and have a profound effect on the entire drug development process. It will also bring financial rewards to companies to offset the cost of paediatric research. See: Lamprill J (Nov 2006) Paediatric Regulation: Reasons to be Proactive: Scrip Drug Delivery p 9-11

    Paediatric Regulation
    • MAAs and line extensions:  must have a compliance checked Paediatric Investigation Plan (PIP) that has either paediatric data, deferral or waiver for each defined paediatric age group subset on submission to any medicines authority in Europe or the application will be rejected.
    • PIPs: The Commission Guideline for writing PIPs has been clarified and revised as most PIPs were failing to meet the required level and detail of information. New guidance available on EMEA website. Unfortunately many PIPs are  delayed at the "clock stop" stage while companies assess their research strategy in light of advice from the PDCO.
    • Feasibility checks: Companies need to be careful that they have not committed themselves to final unworkable paediatric plans and protocols with unrealilstic time lines. Please contact us if you require a value for money feasibility check

    Paediatric Regulation: help with PIPs and other services

    Paediatric Investigation Plan assistance

    PRC does not write PIPs but can recommend companies who do.

    This is a cost effective service as it may prevent delays caused by slow recruitment caused by protocols that are not focused on the research needs of children and their families. PIPs are legally binding. Therefore companies who fail to complete studies in the time they specify will have to apply for a modification to their PIP. In the worst case scenario this could cause failure of MAA if this is not done on time.

    Practical: PRC can review PIPs to help ensure that the proposed paediatric research committed to in the legally binding PIPs is "do-able"  and  likely to satisfy the requirements of the patient and healthcare representatives of the PDCO.

    Ethical: PRC can provide an ethical feasibility review to help anticipate and ameliorate potential ethical issues of the proposed paediatric research outlined in the sponsor company's PIP. Several members of the PDCO have served on ethics committees and the European Commission is particularly concerned that studies should be conducted to the highest ethical standards.

    Further information
    Can be found

    get in touch if you require assistance

    Other PRC services to assist your paediatric clinical trial                                                                
    • Paediatric protocol feasibility
    • Paediatric investigation plan assessment
    • Practical aspects of trial management
    • Fertility and pregnancy test issues in child volunteers
    • Ethical feasibility
    • Strategies for informed consent/assent
    • Good practice for improved recruitment and compliance
    • Paediatric trial rescue
    • PRC expert network
      • Writing PIPs
      • PK/PD advice
      • small metabolite analysis
      • health economics
      • legal services
      • paediatric IT communications
    • Age specific information sheets
    • Parent sensitive information sheets
    • Written by children's author
    • Artwork available for younger children
    • Consent/assent forms
    • Age appropriate fertility information
    • Adult study patient information
    • Articles about paediatric clinical trials
    • PIL leaflet for paediatric medicines (under supervision)
    • Paediatric conference speaker
    • In-house training and workshops
    • Tailored to suit company requirements
    • Informative and enjoyable
    • Anywhere in Europe
    • UK investigator site assistance

    Please get in touch if you require  help

    Back to Top

    “Bobby compliant” website designed by Creative Eye. Photographs of children were sourced ethically and are “model released" I.e. written parental permission obtained for their child to be photographed and picture released to a photo agency. They are embedded to prevent unauthorised persons downloading pictures of children.

    © Copyright Paediatric Research Consultancy 2005-2007. Paediatric Research Consultant is the owner of copyright of this website and its original contents. No part of this website may be published, distributed, extracted, re-utilised, or reproduced in any material form except in accordance with the permissions set out below or as permitted by the Copyright Designs and Patents Act 1988. The following permissions DO NOT APPLY to content supplied by third parties. For permitted use of third party content apply to the relevant content owner.

    You are welcome to use material from this website on the strict condition you acknowledge Paediatric Research Consultancy and quote the website or the relevant journal reference as the source of the material. Extracts must be quoted complete and unmodified.