Prior to 1991, the Somali Agency for Import of Pharmaceuticals and Allied Products (ASPIMA), a government entity, was responsible for the importation and distribution of all the pharmaceutical and medical-related products to both public health facilities and selling Pharmaceuticals and Allied Products to private sector (wholesale) in the country. However, this agency stopped functioning in the early period of the civil war, and with the collapse of the central government.

Somali pharmaceutical sector collapsed in 1991 as a result in the collapse of the health system across many parts of the country. This, together with the combination of insecurity, drought, famine, and other natural disasters has caused huge population displacement resulting 1,5 million IDBS and having some of the worst health indices in the world.

Since January 1991, the public supply system of the pharmaceutical sector in Somalia has been mainly donor dependent through UN Agencies and international NGOs. However, this accounts for about 30% of medicines needs of the country, while the remaining 70% is catered for by a large number of private importers of medicines and an increasing number of private pharmacies and outlets whom are selling medicines and also providing treatment that are operating without any regulatory framework. Due to the very limited human and financial resources, the activities of these private drug importers and private pharmacies are not being overseen by national health authorities (National Medicines Policy, 2014)

NMRA is a medicine regulatory body responsible for regulating all core regulatory functions including registration of medical products, inspection, quality control and product safety of all health products. Currently Somalia does not have a National Medicines Regulatory Authority (NMRA) that is responsible for performing regulatory functions. However, a bill has been developed and endorsed by the cabinet of ministries in 2019 but there are no adequate national guidelines (GLs) for pharmaceutical inspection, product evaluation and registration, import and export control, licensing and inspection of pharmaceutical establishments, post-marketing surveillance and pharmacovigilance. For this reason, Somalia does not perform regulatory activities related to product evaluation and registration, import and export control, licensing and inspection of pharmaceutical establishments, post-marketing surveillance and pharmacovigilance. The absence or lack of functional regulatory authorities with a legal mandate, systems, and capacity to issue marketing authorization and to conduct inspections and subsequently license facilities where medicines are produced and/or stored has created a fertile environment for illegal medicine circulation in the country.

In addition, some of MRA activities have also been technically and financially supported by its partners including WHO and the Intergovernmental Authority on Development (IGAD). The country is signatory of the international convention on the control of narcotics, psycho-tropic substances and precursors. However, legal provisions are not in place for the control of these substances.