- Mots-clés > medicines regulation
- Mots-clés > medicines regulatory authority (MRA)
- Mots-clés > medicines regulatory systems
- Mots-clés > national drug regulation
- Mots-clés > National Medicines Regulatory Authority (NMRA)
- Mots-clés > national regulatory systems - assessment
- Mots-clés > pharmaceutical regulation
- Mots-clés > quality assurance system
- Mots-clés > regulatory framework
- Mots-clés > Strengthening Pharmaceutical Systems (SPS)
(2010; 40 pages)
In October 2009, the Ministry of Public Health (MoPH) of Afghanistan requested that the Strengthening Pharmaceutical Systems (SPS) Program explore options for establishing a comprehensive regulatory framework for food products and medicines in Afghanistan...
The consultants discussed the key findings and recommended priority intervention areas with the two key stakeholders, the MoPH and the USAID.
The assessment findings suggest three overarching priority interventions to establish a functional regulatory body to address the quality of food and medicine products in the country.
These priorities are to-
- Review and update, as necessary, legislation for medicines and for processed and retail food products
- Strengthen quality assurance systems for medicines and processed and retail food products in the industries, government, and academia
- Strengthen the capacity of the National Medicine and Food Board (NMFB) to effectively regulate processed and retail food products and medicine products
To achieve these priorities based on the country’s existing resources and infrastructure, the SPS Program identified the following options for the MoPH to carry out-
Option 1: Strengthen the capacity of the NMFB
Option 2: Help strengthen the existing infrastructure and leverage resources that can be shared in medicine and food product regulatory activities
Option 3: Help establish an independent Afghanistan Food and Drug Administration (AfFDA)
This report discusses the overall and specific objectives, intervention strategies, expected outcomes, and sustainability considerations for each option...
These proposed options are consistent with the Afghanistan Health and Nutrition Strategy of the Afghanistan National Development Strategy and build on existing structures and resources, strengthen local capacity, complement ongoing initiatives without duplication, and leverage existing and potential resources.