- Palabras clave > medicines regulation
- Palabras clave > medicines regulatory systems
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > pharmaceutical regulation
- Palabras clave > regulation
- Palabras clave > regulatory framework
- Palabras clave > regulatory institutional capacity
- Palabras clave > regulatory systems
(2011; 38 pages)
Dukes, G., Gwaza L., Lee, D., Morris, M., Smulko, S., and Wong, S. 2011. Strengthening regulatory system and structure for Medicines and Food Products in Afghanistan: The way forward. Submitted to the U.S. Agency for International Development by the Strengthening Pharmaceutical Systems (SPS) Program. Arlington, VA: Management Sciences for Health.
The MoPH established the National Medicines and Food Board (NMFB) in 2009, as a multidisciplinary body to oversee and catalyze regulatory activities in medicines and food products. The NMFB itself would not have a direct regulatory function; but expected to provide guidance on the technical aspects of regulating medicines and processed food products; however, due to the lack of access to technical expertise and poor coordination among relevant departments, the board has been unable to fulfill its expected role.
In the same year, 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.
Responding to the request of MoPH, an initial assessment was conducted in March 2010 to understand the regulatory system and structure for medicines and food products in Afghanistan. Subsequent to the assessment, 3 options were identified and proposed to NMFB and MoPH for consideration in establishing a regulatory framework for the country.
The NMFB Task Force was established in January 2011 with the mandate to review the three proposed options that were discussed in the assessment report on establishing a Food and Drugs Authority, namely:
- Strengthen the capacity of the NMFB;
- Strengthen the existing infrastructure and leverage resources that can be shared in medicine and food product regulatory activities;
- Establish an independent Afghanistan Food and Drug Administration.
The Task Force aimed to identify the option that is most feasible, sustainable and adaptable to the current situation and recommended in February 2011 the following option:
- Strengthening the NMFB to play an oversight, coordination and advisory role for the regulation of food and medicines;
- Establish a secretariat to provide administrative and technical support to the board ;
- Strengthening the existing structures responsible for implementation of regulation functions.
The selected option and subsequent recommendations reflects the need to implement changes that are viable in the short and medium term.