Author:
K. Al-Essa Reem,A. Al-Bastaki Donia
Abstract
The aim of this chapter is to discuss how competent authorities build quality into their assessment and registration process of medicines and to address possible challenges and opportunities for timely access to safe, effective, and high-quality medicines. Details of quality attributes which characterize the extent of scientific assessments will be the main focus. Such attributes will require solid quality management tools in place the for establishing and maintaining a proper regulatory system. Global harmonization of the regulatory review processes was achieved by the introduction of the Common Technical Document (CTD) which was developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) as the tool for improving the quality of the regulatory review process by standardizing the documents and specifications in the product registration dossier to minimize variations in the of assessment practices and drug approval timelines. Now, with the growing global demand for medicines and the challenges that contribute to drug shortages around the world calls for re-evaluating the impact of CTD/eCTD on the availability of medicines in a no-delay timely man-ner. Therefore, key quality measures must be evaluated to further harmonize and improve the speed and outcomes of the regulatory review process.
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