Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and boost the development of medicines for children.
Patrycja Buczak-Kula
These achievements are highlighted in the PDF icon closing report of the EMA and European Commission (EC) action plan on paediatrics.
The Paediatric Regulation came into force in the EU in 2007 to encourage manufacturers to research and develop medicines for children’s specific therapeutic needs by using a system of rewards and obliging developers to specifically plan the development of their medicine for children (e.g. by integrating it into the development for adults) and submit a corresponding PIP.
A PIP is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for paediatric patients. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed PIP, unless the medicine is exempt because of a deferral or waiver.
https://www.ema.europa.eu/en/news/actions-support-development-medicines-children
Axcellant is pleased to announce the formation of its Advisory Board - a group of distinguished experts in clinical science,…
The FDA and the European Commission are changing the rules of the game simultaneously. The shift is from a single…
Modern nuclear medicine is a high-tech discipline that requires advanced facilities, infrastructure, qualified staff, and know-how. The reliable supply of radionuclides,…
Copyright @ 2026 Axcellant