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Medical Products Dossier Evaluation and Registration
Good Manufacturing Practices and Inspections
Clinical Trials, Pharmacovigilance and Medicines Safety
Quality Control Laboratories
Quality Management Systems
Information Management Systems
Policy, Legislation and Regulation
Description
The Regional GMP Roadmap Framework is a strategic approach as it provides a framework within which countries can develop their pharmaceutical industries to adhere to international Good Manufacturing Practices (GMP).
Abstract
The ECOWAS Regional Pharmaceutical Plan (ERPP) as developed by WAHO describes a comprehensive approach to improving access to essential medicines within the region. A central component of the plan is to reduce the reliance on imported products from outside the region. The document, as approved by Ministers of Health, includes the following mission: “The ERPP seeks to lay down a strategic approach for member states to develop an efficient and effective pharmaceutical sector that would manufacture and supply safe and good quality medicines, for national, regional and international markets”. This document explains this strategic approach as it provides a framework within which countries can develop their pharmaceutical industries to adhere to international Good Manufacturing Practices (GMP). Complying with this standard (as well as being subject to rigorous product development and approval processes) ensures that the quality of medicinal products is assured consistently and that they are safe and efficacious.
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