Paediatric Investigation Plan (PIP) and Pediatric Study Plan (PSP)
What is a pediatric investigation plan?
A Pediatric Investigation Plan (PIP) or Pediatric Study Plan (PSP) is a development plan intended to support the authorization of a medicine for children by ensuring data are obtained through studies in the paediatric population during clinical trials.
Our consultants can advise as to whether a deferral or waiver may be appropriate and can provide a complete PIP writing service as well as any PIP modifications through the lifecycle of the product within the EU or US (especially during development process).
Europe - European Union
In Europe, PIPs are described in Regulation (EC) No 1902/2006 which came into force in the EU on 26 January 2007. This paediatric regulation put in place the PIP to be agreed upon by a new expert committee (the EMA Paediatric Committee [PDCO]); it also regulates a system of obligations and rewards and different transparency/information measures. The objectives are to improve and better protect the health of children with high quality & ethical research, increasing availability of appropriately authorised medicines for children specific information on the use of medicines in the paediatric population.
In the US the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) are the basis of the paediatric US legal framework. The Pediatric review Committee (PeRC) was established by legislation to carry out the activities described under PREA and BPCA. The ultimate goal of PREA and BPCA is to develop new pediatric labelling to encourage the appropriate use of medications to treat pediatric patients. The outline of the pediatric studies the applicant plans to conduct will be compiled in the Pediatric Study Plan (PSP).
How BlueReg can support your PIP/PSP strategy & development
Our consultants can advise you in all steps of the preparation and design of your initial PIP/PSP:
- Assess the right strategy concerning the PIP/PSP scope and timelines to meet your objectives
- Agree on the right condition and indications to be studied through a systemic approach and rigorous methodology
- For all age subsets, assess whether a waiver and/or deferral options can be considered based on available data and propose a risk mitigation
- Interact with agencies in case of Paediatric Scientific Advice, presubmission meeting and all along the PIP procedure.
- Write the corresponding documents: briefing packages, slide decks, paediatric plans and corresponding synopses or justifications for waivers/deferral
- Coordinate on your behalf the full procedures (scientific advice/agency meeting, presubmission meeting, PIP/PSP) and can represent you at agency level in case of face-to-face meeting
Our consultants will also assist you with any PIP amendments in your paediatric developments through the lifecycle of the product within the EU or US, the compliance check procedure or annual deferral report preparation and submission.
BlueReg consultants have built a long experience these past years by supporting our clients in all key steps of the paediatric development.
When should I submit PIP?
The PIP (paediatric investigation plan) should be submitted at the time of the Marketing Authorization Application (MAA) for a new active substance or a new combination.
What is Iris EMA?
Iris is the European Medicines Agency’s portal for electronic submission and validation of marketing authorisation applications and other regulatory procedures.
What is a product specific waiver?
A product-specific waiver may be issued by the Committee when there is no therapeutic, scientific or social justification to carry out studies on a given active substance in children. The request for a product-specific waiver has to be submitted at least 60 days before the MAA submission.
Drug Development Consulting & Strategy
Currently developing a new medicinal product ? BlueReg can provide an end-to-end project plan to guide you from the development of your medicinal product right through to authorization and beyond. We can provide advice and recommendations to ensure the shortest time to market by minimising any possible barriers during the development process and beyond.
Advanced Therapy Medicinal Product (ATMP)
Looking for an Advanced Therapy Medicinal Product (ATMP) classification? BlueReg can guide you to submit a classification application to Health Authorities to determine if your product meets the requirements to be defined as an ATMP.
Early & Expanded Access Programs in France
Looking to reach market earlier ? You can rely on the experience and expertise of our consultants at BlueReg for providing advice and efficient implementation of your Early Access Programs projects in France .
Scientific Advice & Interaction with Health authorities
BlueReg has extensive experience in scientific advice with the European Medicines Agency (EMA) and many national competent authorities. BlueReg can assist with all competent authority meetings.
CMC Product Development
Looking for Chemistry, Manufacturing & Controls (CMC) expertise ? BlueReg ensures CMC regulatory compliance for your projects to meet regulatory agencies requirements and expectations.
Clinical Trial Applications (CTA)
Looking to outsource Clinical Trial Applications? BlueReg offers a variety of services that bring together our global clinical and regulatory expertise to simplify your journey to market. The clinical development process can be complex and can cost your organisation significant time and money.
Orphan Drug Designations (ODDs)
Looking to apply for ODD designations ? BlueReg can determine if your product is eligible for orphan drug designation and provide the necessary support for your EMA/FDA application.
EMA/HTA Parallel scientific advice
Looking for support with your EMA / HTA bodies Parallel Consultation? BlueReg can provide a team of highly experienced consultants specialised in regulatory affairs, market access and scientific writing. Our consultants can advise you on all steps of the procedure and author the required documents required for this important process.
Support for a Paediatric Investigation Plan in the European Union, for a US-based client
BlueReg supported a US-based client with a European Paediatric Investigation Plan (PIP) for their product. BlueReg initially provided guidance with...Learn more