Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations
2008
Regulation on Medicinal Products for Children
publication
Evidence: high
Author Information
Author(s): Birka Lehmann
Primary Institution: Bundesinstitut für Arzneimittel und Medizinprodukte
Hypothesis
The regulation aims to improve the availability and safety of medicinal products for children by ensuring they are adequately tested and authorized.
Conclusion
The regulation establishes a framework to enhance the research and development of safe and effective medicinal products for children.
Supporting Evidence
- Over 50% of medicines used for children have not been adequately tested.
- The regulation aims to ensure that medicines for children are researched and authorized appropriately.
- Children are a vulnerable group requiring specific clinical trials due to their developmental differences.
Takeaway
This study talks about new rules to make sure that medicines for kids are safe and tested properly before they are used.
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website