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Clinicians, pediatric patients, regulators, and more are being considered to further strengthen focus on unmet medical needs.
In the latest closing report of the European Medicines Agency (EMA) and European Commission action plan on pediatrics in February 2023, there were key improvements highlighted to help with children’s medicines and combatting challenges that have been previously mentioned.
For example, over the past four years, EMA and relevant stakeholders wanted to better identify and raise awareness on the areas where medicines for children are particularly needed. Clinicians, pediatric patients, regulators, and more are being considered to further strengthen focus on unmet medical needs.
Another goal of the plan is to adapt regulatory processes to better support innovation to expedite the creation of pediatric investigation plans (PIPs) and to adapt and simplify processes overall. Under framework, like the stepwise PIP agreement, it will become possible in certain cases to agree on a partial development program. This will help to agree on PIPs for innovative medicines where crucial information needed to define certain parts of the plan is not yet available.
Lastly, an increased alignment of data requirements between decision-makers will help to facilitate the compatibility of pediatric requirements between regulators, international partners, FDA, and more. This work has also been seen through the European network of pediatric research at EMA (Enpr-EMA) to help align international requirements for pediatric clinical trials authorization and standards.
The pediatric action plan was established to provide some immediate solutions to these challenges under the current regulatory framework. All these initiatives will contribute to the application of the Pediatric Regulation, with the adoption of the proposal expected by March 2023.
Source: European Medicines Agency