- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Palabras clave > medicines quality assurance assessment
- Palabras clave > medicines regulatory systems
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > Quality assessment
- Palabras clave > quality assurance - medicines
- Palabras clave > Quality Assurance of Pharmaceuticals
- Palabras clave > quality assurance system
- Palabras clave > quality of medicines
- Palabras clave > regulatory assessment
- Palabras clave > regulatory control
(2011; 81 pages)
The Afghanistan Ministry of Public Health (MoPH) with technical assistance from the Strengthening Pharmaceutical Systems (SPS) Program carried out a qualitative survey of medicines quality assurance assessment in Afghanistan.
This survey was undertaken to assess the entire pharmaceutical sector, both public and private, to establish existing capacities for the medicines regulation and control framework.
The findings of this qualitative survey, together with the findings of the separately carried out quantitative medicines testing survey, will lead to the development of policies and strategies for a sustainable medicines quality assurance system for Afghanistan...
There is weak capacity for existing medicines regulation and control for both public and private sectors, and no functional medicine regulatory authority in Afghanistan. Structures, procedures, and policies to properly regulate the pharmaceutical sector for quality assurance are lacking. There is no GMP inspectorate or national GMP guidelines. Although policies, legislation, and regulations do exist, implementation is weak due to insufficient budgets, infrastructure, and technical human resources. Afghanistan does not have a mechanism or system for monitoring the quality of medicines, adverse medicine reactions, and medication errors. There is no system for pharmacovigilance.