Applying for a Paediatric investigation plan (PIP): review of the EMA guidelines

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04.06.2024                                                                                              

 

To apply for different types of peadiatric applications, such as PIP, starting from 4 June 2024, it is necessary to use the IRIS platform. IRIS is an online platform that securely handles regulatory and scientific procedures for pharmaceutical products. This platform should be used by any PIP applicant, even those not based in the European Union or without an authorized contact based in the EU. Before submission, it is necessary to request a research product identifier (RPI) through the IRIS system.

It is no longer necessary to send a letter of intent (LoI) to let EMA know about applicant’s intention to apply for a PIP.

It is possible to submit a single PIP for all corresponding marketing authorizations related to one medicinal product in case of a single applicant.

The list of paediatric submissions that can be done through IRIS is as follows:

  • Initial Paediatric investigation plan (PIP)
  • Updates to an approved PIP
  • Waivers
  • Check of compliance
  • Annual reports on paediatric deferred measures
  • Confirmation of applicability of a class waiver
  • Discontinuation of a paediatric product development

 

An applicant may request from EMA a free of charge scientific advice on all appropriate tests and research studies to be conducted during a paediatric medicines’ development. This may also be done using the IRIS platform.

 

For innovative paediatric medicines applications, there is a pilot stepwise paediatric investigation plan (sPIP) programme that is applied in cases when there is limited crucial information available to outline certain parts of the PIP. This programme requires submission of a complete PIP as soon as necessary data becomes available.

 

 

Source: European Medicines Agency (EMA), summary by Nataliia Vietchinkina

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