The goals of this situation analysis were to evaluate the current status of the PFDA’s overall regulatory information management system, with a focus on medicine registration data management, and to develop recommendations and an action plan to cultivate a more robust regulatory information management system, including the required IT solutions to manage licensing of drug … Read more
The DNME of the MINSA recognizes the importance of regulating pharmaceutical products and wants to introduce a new policy to mandate product registration to better control the safety, quality, and efficacy of pharmaceutical products. The National Department of Medicine and Health Products of the DNME is the responsible unit for managing pharmaceutical product registration. However, … Read more
As a part of its ongoing support to build the capacity of the DGDA, the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) team conducted a rapid assessment of the capacity of the Good Manufacturing Practices (GMP) inspection program at the Directorate General of Drug Administration (DGDA). GMP is part of the quality assurance … Read more
SIAPS conducted a review of regulatory and quality assurance efforts in the GMS with the following objectives— To inform PMI of past and current initiatives to improve the capacity of the region to combat counterfeit, substandard, and banned antimalarial medicines To understand the current barriers to effective medicine quality control for malaria To recommend specific … Read more
