The regulatory authority in South Sudan, under the MoH is the South Sudan Drug and Food Control Authority. The main objective of the authority is to exercise general supervision, control and co-ordination over all matters relating to the pharmaceutical industry and to be the principal instrument of Government in the implementation of all policies relating to drugs, poisons, chemicals, cosmetics, and foods meant for human or animal use.

The authority’s board conducts the registration of drugs, poisons, chemicals, cosmetics, medical devices and foods in the country. The board evaluates the products for safety, efficacy, cost effectiveness and public health benefits or other considerations before listing them in the provisionally registered inventory. Until granted a product Marketing Authorization or ordered by the Board not to be manufactured, imported, exported or sold, such products shall have the status of provisionally authorized or registered. No person is allowed to import, manufacture, export or sell any drug, poison, chemical, cosmetic, medical device or food not listed in the Inventory, without the prior written permission of the Board or until after a product Marketing Authorization has been granted in respect of such product in accordance with the provisions of section 36of this Act.

Any person carrying on the business of manufacturing, importing, exporting, compounding, storing, dispensing, selling, supplying or otherwise distributing regulated products are required to possess a valid license issued by the Authority in order to carry out that activity in the specified premises. The Authority issues a license to the license applicant, after having evaluated and becoming satisfied that the premises are suitable, and the applicant can safely and effectively carry on with their business in compliance with all applicable law, regulations and ethical standards. Individual practitioners like pharmacists are also required to get their own license.

The Board, in consultation with the Minister may appoints, as necessary, inspectors who enforces provisions of the inspection Act and delegate powers to appoint more inspectors. Inspectors appointed by the state ministries are expected to inspect health facilities, retail pharmacies and drug store premises within the administrative jurisdiction of the state. They are to comply with requirements for education and training prescribed by regulations. They are issued with an Inspector’s Badge and formal identification that are signed by the Secretary-General or the designated authority in the state. Upon request by a person affected by the Inspector’s exercise of powers conferred by this Act, the Inspector shall exhibit the Inspector’s Badge and identification issued.

No person can import, export or transport regulated products for commercial or public use into South Sudan without having a valid license issued by the Authority in relation to such export, import or transportation. The license is valid for the period specified by the Board and states the range of authorized Regulated Products to be imported during the validity period of the license. Any person who imports any regulated product is to keep a record in the prescribed form of all imports.

The Board shall establish Pharmaceutical Quality Control Laboratory to carry out the required tests and analysis and conduct research to ensure that Regulated Products meet quality requirements as to contribute towards assuring quality, safety and wellbeing of the public. The laboratory shall support the pharmaceutical inspectorate in routine monitoring, inspection and supervision of the Regulated Products that are manufactured, imported, exported or distributed in the pharmaceutical supply chain.

No person can conduct a Clinical Trial of any Medicine without the prior written authorization of the Authority granted with approval of the Minister. Any person who desires to conduct a Clinical Trial with respect to a Regulated Product is to submit to the Secretary General an application in the prescribed form, signed by him or her and accompanied by fees as may be prescribed.
In case of a Regulated Product used for the treatment of animals, the application specifies the kinds of animals that will take part in the Clinical Trial, and the names and addresses of the owners of such animals. Where a clinical trial is to be conducted in a hospital or other medical institutions, the application referred above, is to be countersigned by the medical superintendent or a senior medical officer of a comparable rank of such hospital or medical institution.

South Sudan’s MRA is controlled by the Food and Drug Control Authority which is under the MoH. The ministry has a website where it shares necessary information. However, being a young country that just recently gained independence, most of the sectors in the MoH and MRA thereof, has not been well established. The website exists but with very limited information. However, South Sudan joined the East African Community after its independence and is set to get a lot of benefits from the region’s MRH website that already exists.