What are the regulatory requirements for pediatric medicines?
Regulations in the US and EU both require and incentivize (via pediatric exclusivity) development of pediatric medicines. These regulations are designed to ensure that every new drug will be evaluated for use in pediatric patients and studied in this population when appropriate.
A key requirement is the submission of detailed plans that outline the studies to be conducted as part of the pharmaceutical and clinical development program:
- EMA – Paediatric Investigation Plan (PIP)
- FDA – Pediatric Study Plan (PSP)
The regulatory agencies require that companies demonstrate the “palatability” of drug products in pediatric patient populations as part of the pharmaceutical and clinical development program (unless a PIP or PSP waiver is granted).
So what is a palatable drug product?
Many Active Pharmaceutical Ingredients (API) are extremely bitter or have other aversive sensory attributes such as a malodor, trigeminal irritation, or a gritty texture that can adversely affect doing compliance.
There are many definitions of “palatable” – dictionaries, expert opinions and regulatory perspectives. However, the shortcoming of all of them is that they are subjective.
Senopsys has advanced a definition of “palatable” that is based on the scientific principles of perception:
are below the recognition threshold”
A key feature of Senopsys’ definition of palatable is that it has a measurable endpoint.
