The development of paediatric formulations and presentations is necessary to ensure that children of all ages and their caregivers have access to safe and accurate dosage forms of medicines.
In line with Article 15 of the Paediatric Regulation, marketing-authorisation applicants are required to include in their paediatric investigation plan (PIP) any measures to adapt the formulation of the medicinal product to be age-appropriate in different subsets of the padiatric popluations.
The Guideline on pharmaceutical development of medicines for paediatric use provides harmonised recommendations on the aspects to be considered in the development of a specific product for use in the paediatric population, or a specific subset.
In addition, the Reflection paper on the formulations of choice of children provides further information on the available information on paediatric formulations.
Use of excipients in paediatric formulations
Constituents of the formulations other than the active substance(s) should be chosen appropriately, avoiding any excipients that are potentially toxic or unsuitable for children.
Some aspects of the choice of excipients in respect to carcinogenicity, genotoxicity, and toxicity for reproduction were reviewed by the Committee for Medicinal Products for Human Use. The review includes, but is not limited to, excipients used in medicinal products intended for children:
Paediatric formulations in the PIP decision
Quality aspects in PIP applications are reviewed by the Formulation Working Group of the Paediatric Committee (PDCO-FWG). The following criteria are used to select products for detailed analysis by the PDCO-FWG:
- List of criteria for screening PIPs with regard to paediatric specific quality issues and referring them to the PDCO-FWG for discussion
This document provides an overview of the criteria applied during screening of PIP applications submitted to the Agency. New PIP applications are checked against these criteria and, if needed, referred to the PDCO-FWG for detailed discussion.
The PDCO-FWG may issue recommendations to the PDCO regarding the measures and studies needed to adapt the formulation(s), pharmaceutical form(s) and/or presentation(s) for paediatric use. These may be translated into key elements to be included in the PIP opinion/decision. The following document provides examples of quality-related measures that can be included in PIP opinions as key elements:
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- Guideline on pharmaceutical development of medicines for paediatric use (2013-07-31)
- CHMP scientific Article-5(3) opinion on the potential risks of carcinogens, mutagens and substances toxic to reproduction when these substances are used as excipients of medicinal products for human use (2007-10-18)
- Examples of key binding elements in the paediatric investigation plan decisions (2014-02-05)
- List of criteria for screening paediatric investigation plans with regard to paediatric specific Quality issues and referring them to the PDCO FWG for discussion (2014-02-05)