In Sudan, the regulatory system of pharmaceuticals has been started after independence during the sixties of the past century. In 1963, the first Pharmacy and Poisons Act has been developed and according to this act, the Directorate General of Pharmacy – FMoH, has been assigned to handle the pharmaceuticals regulatory affairs and licensing of pharmaceutical facilities. The situation remained the same until the 1963 Act was amended in 2001. According to 2001 Act, the supervisory role continued to be handled by Federal Ministry of Health through the Directorate General of Pharmacy and the States’ Directorates of Pharmacy. In 2001, the Federal Pharmacy and Poisons Board (FPPB) has been established in accordance with the Pharmacy and Poisons Act 2001. The FPPB continued to operate under the umbrella of the Directorate General of Pharmacy - FMoH until 2007. Since that year, the FPPB became National Medicines and Poisons Board (NMPB) which is semi- autonomous body under the direct supervision of the Federal Minister of Health and the Secretary General is the Executive in charge. Its members include representatives of institutions and entities related to the control of medicines as well as other medical products. In 2009, the 2001 Act was amended to become the Medicines and Poisons Act of 2009 which is currently in force. According to 2009 Medicines and Poisons Act – Article (6) - the NMPB becomes the executive authority responsible for setting legislations, requirements and guidelines regulating the registration, importation, manufacturing, inspection, pricing and quality control of human and veterinary medicines, medical devices, consumables, medicinal products and cosmetics.