Drug Approval Process for Pediatric Patients

Abstract

Before placing a drug on the market for human use, it must be comprehensively studied in preclinical and clinical studies to ensure it is safe, high-quality and effective to be used in the target population. Nevertheless, there are not enough studies carried out for the pediatric population. Many of the medications currently used to treat the pediatric population have not been authorized for such use. Problems resulting from inadequate adaptation of adult medications for children include inadequate dosing which leads to increased risk of adverse reactions including death, ineffective treatment, non-availability to the pediatric population of therapeutic advances, non-suitable formulations, lack of formulations and inadequate administration routes, as well as use of magistral or officinal formulations to treat the pediatric population which may be of poor quality. The development of pediatric medicines will lead to safe and accurate administration, reducing the risk of medication errors, improving adherence to medication and improving therapeutic outcomes in children. For these reasons, it is necessary that the regulatory authorities in each country encourage the research and development of pediatric medicines. The objective of this article was reviewing the pharmacological and regulatory aspects involved in the development of pediatric medications, as well as describing the current status of pediatric drug development in Mexico.