The pharmaceutical regulatory authority in Sudan is called the National Medicines and Poisons Board (NMPB) and its executive arm - the National General Directorate of Pharmacy (NGDOP). The NGDOP regulates mainly four aspects of medicines use: safety, quality, efficacy and price. When applying to register any medicine, manufacturers and importers are required to furnish the FGDOP with a dossier of information including: the indication of the medicine, its efficacy, side effects, contraindication, warnings on usage by high risk groups, price, storage and disposal.

The NGDOP is responsible for the appraisal, and registration of all medicines and other pharmaceuticals for both human and veterinary use on the Sudan market. It is also responsible for the verification of the competence of manufacturing companies, the manufacturing plants, the ability to produce substances or products of high quality before registering these companies and allowing them to apply for registration of their products in Sudan.
When necessary, visits conducted to those companies and their manufacturing units, to verify their compliance with good manufacturing practice recommended by the WHO. The applicant for registration of pharmaceutical product must submit all prescribed data and the certificates required under the WHO certification scheme for a pharmaceutical product moving into international commerce, and any other information that is necessary for assuring the quality, efficiency and stability of the product through its shelf life.

Licenses are granted for a period of one year and may be renewed at the end of December every year (applications to the relevant DOP before expiry of the current license). To improve the effectiveness of the public pharmacy, resources should be switched towards areas of need, reducing inequalities and promoting better health conditions. Medicines are financed either through cost sharing or full private. The role of the private services is significant.
The present policy of the national health–care system in Sudan is based on ensuring the welfare of the Sudanese inhabitants through increasing national production and upgrading the productivity of individuals. The strategy of price liberalization and privatization had been implemented in Sudan over the last decade and has had a positive result on government deficit. The licenses being issued include, retail pharmacy license, manufacturer’s license for both public and private firms.

In Sudan, legal provisions exist allowing for appointment of government pharmaceutical inspectors to inspect premises where pharmaceutical activities are performed. By law, inspections have to be performed and are a pre-requisite for licensing facilities. The inspection requirements are the same for public and private facilities. However, the regulatory authority has its own inspectors.

Medicines are granted the legal authority for importation. Importation is only allowed through certain ports of entry. Legislations exist that allow for inspection of imported pharmaceutical products at the authorized port of entry upon arrival. Imported medicines are then sampled out and tested before being distributed into the market.

A laboratory exists in Sudan for Quality Control testing. Samples are collected by government inspectors for post-marketing surveillance testing from locally manufactured or imported medicines. Medicines that fail to meet the required quality standards are not allowed for distribution or entry into the country, if imported. The results of the quality control testing are not publicly available. Only recalled medicines are published on the MRA website.

In Sudan, legal provisions exist to control the promotion and/or advertising of all medicines. The National Medicines and Poisons Board (NMPB) is responsible for regulating promotion and/or advertising of medicines. Legal provisions prohibit direct advertising of all medicines to the public. Legal provisions require a pre-approval for medicines advertisements and promotional materials. Guidelines and regulations exist for advertising and promotion of non-prescription medicines. There is no national code of conduct concerning advertising and promotion of medicines by marketing authorization holders.

In Sudan, legal provisions exist requiring authorization for conducting Clinical Trials by the MRA. Laws require the agreement by an ethics committee or institutional review board of the Clinical Trials to be performed. Registration of the clinical trials into international/national/regional registry is not required by law.

There are no legal provisions in the Medicines and Poisons Act that provide for pharmacovigilance activities as part of the MRA mandate. Legal provisions do not exist requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA. The national medicines and poisons board emphasize the importance of pharmacovigilance activity. A national pharmacovigilance center linked to the MRA exists in Sudan. The center does not publish an ADR bulletin regularly. An official standardized form for reporting ADRs is used in Sudan and a national ADR database exists. ADRs are monitored in at least one public health program.

Sudan has a well detailed MRA website for sharing its pharmaceutical information with the parties of interest both locally and internationally. The NMPB website contains information on most of the regulatory functions, including, pharmacovigilance, licensing guidelines, registration, importation policies, student researches and the national laboratory activities. In addition to this, Sudan is also a committed member state of IGAD REC and stands to gain the benefits of the MRH that occurs within the region.