Strengthening Regulatory Systems

SPS assisted the Ministry of Public Health (MoPH) in establishing a functional regulatory framework, including supporting efforts to bolster governance and develop and implement required laws, regulations, and policies to support an improved pharmaceutical network. An initial major objective was to integrate effective pharmaceutical management strategies into national policies to support activities and ensure that progress would be sustainable.

Project Accomplishments

The National Medicine and Health Product Regulatory Authority was established in 2016, with detailed terms of reference for all departments.

Five pharmaceutical policy and 24 regulatory documents were updated or established. These include a new National Medicine Policy aligned to international standards, endorsed by the MoPH, and revised medicine laws, regulations, and standard operating procedures to comply with the new policy.

The project provided technical support in the revision of Afghan Medicines and Health Products Law and created the country’s first Essential Medicines List and Licensed Medicines List.

The project conducted a medicine quality study and rapid quality assurance (QA) assessment, which led to initiating interventions to improve pharmaceutical QA policies and strengthen the regulatory environment for drug and food safety. With technical assistance from SPS, the Minister of Public Health endorsed the National Policy for Pharmacovigilance in 2017.