According to the WHO pharmaceutical country profile, the Pharmacy and Drug Management (DPM) of Cote d’ Ivoire performs the following regulatory functions: market authorization, pharmacovigilance, clinical trials, market and quality control, inspection, licensing, promotion and advertisement of medicines and import control.
The Directorate of Pharmacy, Medicines and Traditional Medicine is the drug regulatory authority oversees medicines regulation and is responsible for keeping the National Medicines Registry up to date. The regulatory body is also responsible for ensuring that the country is compliant with the requirements of the World Health Organization’s Prequalification of Medicines Program. This program helps ensure that medicines supplied by international procurement agencies for distribution in countries with limited resources meet acceptable standards of quality, safety, and efficacy.
In December 2017, the Global Health Supply Chain Technical Assistance Francophone Task Order provided technical and financial support to the Drug Regulatory Authority of the DRC to review the Medicines Registry authorized for use in the country. The review identified that half of all the authorizations (2,322) issued in the period of January 2010 to September 2017 were expired. Additionally, 109 market authorizations were identified to expire within three months after the review (USAID Global Health Supply Chain Program, 2018).
SIAPS also supported the DRA to implement a pharmaceutical regulatory system and develop a comprehensive national pharmaceutical policy framework. The National Essential Medicine List, which included 13 lifesaving commodities endorsed by the UN Commission on Life-Saving Commodities for Women’s and Children’s Health, was updated (SIAPS, 2016).
Djibouti does not have a national medicine regulatory authority currently. However, it has a ministry of health department that helps with the administration of the country’s health activities.
The website for the ministry contains information about major pandemics like covid19 and publications on HIV/AIDS. Information about the current health statistics of the citizens of Djibouti is also uploaded in this website. The country relies on IGAD MRH for their medicine regulation.

To register a drug with DPM, the applicant has to set an appointment by creating an account or logging-in through their online portal. To create an account, the applicant first must enter in their username and password. The second stage involves entering in an authorization number they got from DPML.

An ADR reporting form is available on the website. The form asks for information such as the patient’s personal information, the type of health facility from which the Report is being made, the medical history of the patient and the description of the adverse event. Cote d’Ivoire is a member of WHO’s Uppsala Monitoring Centre for international drug monitoring.
In Egypt, there are legal provisions in the Medicines Act that provide for pharmacovigilance activities as part of the MRA mandate. Marketing Authorization holders are required to continuously monitor the safety of their products and report to the MRA. The country has a national pharmacovigilance centre which is linked to the MRA. There is a national ADR or pharmacovigilance advisory committee able to provide technical assistance or causality assessment, risk assessment, risk management, case investigation and, where necessary, crisis management including crisis communication in the country.

DPML has a web portal that allows applicants to register their products through. There is also a portal for people to make pharmacy sites allocation requests. This can be access via: http://pharma.dpmlci.net/. The user should already have an account.

The pharmaceutical regulatory body in Egypt is the Egyptian Drug Authority (EDA) operating and working under supervision of the Ministry of Health (MoH) in Egypt. The EDA comprises three independent organizations consisting of the following:
•      Central Administration for Pharmaceutical Affairs (CAPA): which is mainly responsible for the registration and pricing of medicines, and inspection of pharmacies and manufacturing facilities.
•      The National Organization for Drug Control and Research (NODCR): which is responsible for quality control of pharmaceutical products, medicines, medical plants, cosmetics, raw materials, insecticides, and products from natural origin.
•      National Organization for Research & Control of Biologicals (NORCB): which is responsible for the marketing authorizations and licensing activities.

In Egypt, legal provisions require marketing authorization (registration) for all pharmaceutical products on the market, however exceptions/waivers for registration do exist. Mutual recognition mechanisms are in place: under certain requirements: for prescriptions only, reports from physicians, through an Egyptian drug distribution company. Explicit and publicly available criteria exist for assessing applications for marketing authorization of pharmaceutical products. There are legal provisions requiring the MRA to make the list of registered pharmaceutical products publicly available and update it regularly. This register is updated every 10 years. Legal provisions require a fee to be paid for Medicines Market Authorization (registration) based on applications.

Legal provisions exist allowing for appointment of government pharmaceutical inspectors. Inspectors are permitted to inspect premises where pharmaceutical activities are performed. The inspections are required by law and are a prerequisite for the licensing of public and private facilities. Where inspections are legal requirements, these are the same for public and private facilities.

Legal provisions exist requiring authorization to import medicines. Laws exist that allow the sampling of imported products for testing. Legal provisions exist requiring importation of medicines through authorized ports of entry. Regulations or laws do not exist to allow for inspection of imported pharmaceutical products at authorized ports of entry.

In Egypt, legal provisions exist requiring manufacturers to be licensed and to comply with Good Manufacturing Practices (GMP). Good Manufacturing Practices are published by the government. Legal provisions exist requiring importers/wholesalers/distributors to be licensed and wholesalers and distributors to comply with Good Distribution Practices. All pharmacists and private and public pharmacies to be licensed.

A laboratory, which is a functional part of the MRA, exists for quality control testing. Medicines are tested for several reasons including, quality monitoring in the public and private sectors, for product registration and for public procurement prequalification.

The Medicines Regulatory Authority (Central Administration for Pharmaceutical Affairs) is responsible for regulating promotion and/or advertising of medicines. Direct advertising of prescription medicines to the public is prohibited and pre-approval for medicines advertisements and promotional materials is required.

Legal provisions requiring authorization for conducting Clinical Trials by the MRA do not exist. There are no laws requiring the agreement by an ethics committee or institutional review board of the Clinical Trials to be performed. Clinical trials are not required to be entered into an international/national/regional registry, by law. Neither do legal provisions for GMP compliance of investigational products exist. Sponsor investigators are not legally required to comply with Good Clinical Practices (GCP).

The Division of Clinical Services is responsible for the supervision of diagnostic, curative, and rehabilitative services. It oversees the provision of health care and supervises the treatment and care given in all the health facilities of MoH. It also collaborates with associations of health professionals to regulate professional conduct. The division is also responsible for the development of policy and guidelines for medical practice, in accordance with MoH Quality Assurance Program. It has three units: Medical Services Unit, Treatment and Care Unit and Licensing Unit.

There has been no National Health Act or Regulation in Eritrea but there are several proclamations on control of drugs, cosmetics and sanitary items, tobacco control, control of private practice and control of female genital mutilation (FGM).

Applications for the registration of a pharmaceutical product submitted to the NMFA for the very first time is considered as a new application. Applications for registration of medicines from new manufacturing facilities not inspected and approved by the NMFA are also expected to submit a site master file (SMF) of the plant in which the product is manufactured. The NMFA may also conduct GMP inspection.

Swaziland currently has no national medicine regulatory authority. However, the Ministry of Health oversees the importation and regulation of medicines in the country. The pharmaceutical and medicines section of the website of the Ministry of Health (MoH) has various documents (in MS-Word and Excel formats) on guidelines for pharmaceutical imports, medicine list with guidance notes, medicines guidance database and call for registration of medicines letter. However, the Swaziland medicine importer registration form is not available on the Ministry of Health website.

From the guidelines given, there is currently no local or subsidiary pharmaceutical manufacturing firm in Eswatini. All medicines are imported. To ensure that all imported medicines are of standard quality, importers are to register medications with the Ministry of Health. Based on approval from registration, permits will be given to companies and person based on their set standards. The Eswatini medicine listing was downloaded in an excel format; however, there was no data on medicines available in the file.

Ethiopian Food, Medicine and Healthcare Administration and Control Authority (EFMHACA) is empowered by the Council of Ministers Legislation 189/2010 as the governing body for medicine regulation in Ethiopia. It is granted to regulate their manufacture, distribution, marketing, prescription, labelling and dispensing

Medicines registration in Ethiopia is carried out by MRAs to ensure that a medicinal product has been adequately tested and evaluated for safety, efficacy, and quality; and the product information provided by the manufacturer is accurate.
Ethiopia has a legal basis for marketing authorization of the pharmaceutical products with guidance for applicants and standard operating procedures for assessors. EFMHACA has a single advisory committee and is not currently participating in regional harmonization for registration, even though Ethiopia is very recently working towards harmonization of quality assurance for pharmaceutical and medical products with Intergovernmental Authority on Development (IGAD) member countries.

The market authorization process in Ethiopia includes manufacturing premise inspection for GMP compliance, assessment of product dossiers and laboratory testing, where applicable. The requirements for Ethiopian market authorization are: the medicinal product has to be included in to national medicine list, the manufacturing site has to be approved and certified for compliance with GMP either by EFMHACA or other recognized stringent regulatory authorities and such GMP certified or waived manufacturers have to submit application for dossier evaluation and product quality assessment accompanied with application fee.

EFMHACA is responsible for manufacturers, importers and wholesaler’s inspection and licensing. However, EFMHACA’s proclamation does not include requirements for obtaining licenses, terms, and conditions for suspending or revoking activity and product licenses. It does not define the norms, standards, and specifications to be applied in assessing the quality, safety, and efficacy of medicinal products. These points and other similar details were left to be stated in the directives and guidelines to be prepared by EFMHACA based on the proclamation.
The country has a clear guideline on how to avail the pharmaceutical registration and regulation services to the citizens and other parties of interest. It shares this information in its NMRA website and MoH website in detail.