Importance of the Core Data Sheet (CDS) management as an instrument for the periodic update of the monograph and leaflet of pharmaceutical products for human use

Abstract

The Central America and Caribbean region has regulations for the registration of pharmaceutical products for human use in the different countries and these include a serie of guidelines related to drug labeling. The objective of this review is to expose the importance of the Core Data Sheet (CDS) management as an instrument for the development and update of monographs and leaflets of innovative drugs for human use and its context in the region. A systematic search was made in diverse databases with keywords in English and Spanish. In addition, international guidelines from strict health authorities were consulted and local regulations of the countries were also assessed. According to the retrieved information, the Core Data Sheet (CDS) constitutes a valuable source of information of safety and efficacy of drugs. Its implementation allows the development and update of drug monographs and leaflets of innovative drugs in a continuous manner for the Central American and Caribbean regions