A narrative review on problems in product quality, regulatory system constraints, and the concept of quality by design as a solution for quality assurance of African medicines.

ABSTRACT:

Background

The provision of medicines with confirmed quality and efficacy is critical for maintaining the public health and building confidence in the healthcare systems. However, the presence of poor-quality medicines still presents a significant challenge in the pharmaceutical landscape across the African regions. This is further exacerbated by the lack of consistency or discrepancy in the current regulatory framework. As a consequence, given the current constraints, a robust regulatory structure that can guarantee the supply chains attainment of the intended medicinal product requirements are required.

Objective

The review aimed to provide a detailed analysis of the quality issues in the pharmaceutical supply in Africa, highlighting the challenges and proposing potential

SUBMITTER: Hassen HK 

PROVIDER: S-EPMC11484627 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature