Paediatric Research Consultancy

  Helps optimise paediatric trial planning to improve recruitment and compliance

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  • Paediatric Investigation Plans

    General information about Paediatric Investigation Plans

        Paediatric Investigation Plans

    Paediatric Investigation Plans (PIPs) were introduced by the European Commission to help ensure that medicines for children are included in the mainstream drug development process in Europe, rather than as an optional extra. This means that children will benefit from more effective treatments and companies will be rewarded for the extra work and higher costs of paediatric drug development.

    From the introduction of Regulation (EC) 1901/2006 Medicinal Products for Paediatric Use, which entered into force on 26 January 2007 there has been a massive paradigm shift in European drug development. It is now mandatory for pharmaceutical companies to submit a Paediatric Investigation Plan to the Paediatric Committee (PDCO) at the European Medicines Agency (EMEA) around the end of the first phase of testing a new drug in adults.

    Critically there have been misunderstandings – the aim is NOT to test medicines on children at an earlier and earlier phase as in most cases this would neither be safe nor ethical. Rather it is to create a written, flexible dialogue between the EMEA, Competent Authorities and Industry so that medicines that benefit children can developed in tandem with – but not delay the time to market of the same new adult drug.

    However  if a company submitting a Marketing Authorisation Application in Europe does not have an approved Paediatric Investigation Plan in place, the MAA will be automatically rejected, leading to huge losses of time, sales and thus return on investment (ROI). This will benefit competitors and anger share-holders. Companies may also suffer the humiliation of being “named and shamed” on the EMA website.

    The Paediatric Investigation Plan is legally binding and must outline how the company proposes to test the medicine in order to benefit child health and wellbeing. However if there is no known indication for use in children the company may apply for a waiver which must be approved before MAA submission.

    This is complex because the disease that the drug treats in adults may not be found in children (e.g. Alzheimer’s) but may benefit children in other ways (e.g. paediatric brain injury). If for example it is not safe to test medicines in children yet or adult trials are still on-going, the company must apply for a deferral which again must be approved before MAA submission.

    There is the added problem that many pharmaceutical companies are inexperienced in testing medicines for children. The safety net of free scientific advice will be available from experts at the EMEA – and of course no paediatric research can take place without ethics committee and member state medicines regulatory authority approval. However companies may lose a massive amount of time and money if they are not familiar with the practical aspects of paediatric trial management – and could commit themselves to a binding agreement with a final, unworkable protocol.

    Help with Paediatric Investigation Plans

    • PRC’s proposed PIP feasibility review for practical and ethical considerations
    • PRC’s trusted expert network of companies that write PIPs

    Please contact PRC for further information.

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