Egypt
Official Name: Arab Republic of Egypt
Capital: Cairo
Independence Day: 28 February 1922
Currency: Egyptian Pound (EGP)
Indicators
Regulatory Authority
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.
• 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.
Marketing Authorization (Registration)
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.
Regulatory Inspection
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.
Import Control
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.
Licensing
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.
Market Control and Quality Control
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.
Medicines Advertising and Promotion
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.
Clinical Trials
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).
Pharmacovigilance
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.