Current Edition

Paediatric Regulations are Permanent: Approaches for Overcoming the Challenges of Paediatric Drug Development

Global regulators have, for many years, put in place provisions and regulations to ensure that children’s specific medical needs are addressed through structured clinical research, in order to advance the development of safer and effective drugs and to generate information to guide prescribers in using these medicines in children. Philippa Smit-Marshall at PharmaNet/i3 provides an overview of how these measures have resulted in 445 drugs having paediatric labelling, with the conduct of over 400 studies in more than 170,000 patients.