Strengthening regulatory system and structure for Medicines and Food Products in Afghanistan: The way forward

The NMFB's primary role is to provide guidance on the technical aspects of regulating medicines and processed food products, but it has been unable to fulfill this role due to a lack of access to technical expertise and poor coordination among relevant departments. The MoPH requested that the Strengthening Pharmaceutical Systems (SPS) Program explore options for establishing a comprehensive regulatory framework for food products and medicines in Afghanistan. In response, an initial assessment was conducted in March 2010 to understand the regulatory system and structure for medicines and food products in Afghanistan. The assessment identified three options for establishing a regulatory framework, which were proposed to the NMFB and MoPH for consideration. The NMFB Task Force was established in January 2011 to review the proposed options and identify the most feasible, sustainable, and adaptable solution. The Task Force recommended strengthening the NMFB to play an oversight, coordination, and advisory role for the regulation of food and medicines, establishing a secretariat to provide administrative and technical support to the board, and strengthening the existing structures responsible for implementing regulation functions. The selected option and subsequent recommendations reflect the need to implement changes that are viable in the short and medium term. The proposed Action Plan to implement the recommendations focuses on strengthening the NMFB capacity and improving the effectiveness and efficiency of medicines and food regulatory functions. The Action Plan to strengthen the NMFB capacity includes redefining the NMFB's Terms of Reference (ToR) as a policy advisory and oversight body, establishing a secretariat, and orienting the NMFB on its redefined ToR, updated information on the current regulatory system, and duties, roles, and responsibilities for different stakeholders. The Action Plan to improve the effectiveness and efficiency of medicines and food regulatory functions includes drafting or updating legislation, defining lines of accountability, implementing documentation and record-keeping activities, developing tools, and increasing the effectiveness of medicine law implementation. The chosen option was successfully reported and approved by the Deputy Minister of MoPH and NMFB members in March 2011. The NMFB approved the Task Force recommendations and the plan of action to implement the recommendations. The regulatory system for medicines and food products in Afghanistan is currently characterized by a lack of access to technical expertise and poor coordination among relevant departments. The NMFB has been unable to fulfill its expected role due to these challenges. The proposed Action Plan aims to address these challenges and improve the effectiveness and efficiency of medicines and food regulatory functions in Afghanistan. The proposed regulatory framework for food products and medicines in Afghanistan is based on the principles of good governance, transparency, and accountability. The framework aims to ensure that medicines and food products are safe, effective, and of good quality, and that the regulatory system is responsive to the needs of the public and the pharmaceutical industry. The implementation of the proposed regulatory framework will require the involvement of various stakeholders, including the NMFB, the secretariat, and the existing structures responsible for implementing regulation functions. The framework will also require the development of new tools and procedures, such as a registered medicines database, operating procedures, manuals, and guidelines. The proposed regulatory framework for food products and medicines in Afghanistan is expected to have a positive impact on public health and the pharmaceutical industry. It will help to ensure that medicines and food products are safe and effective, and that the regulatory system is responsive to the needs of the public and the pharmaceutical industry.