Overview

With a diverse economy combined with large ratio of Pharmaceutical imports, the Republic of Ghana boasts a viable future for foreign medicine and medical device manufacturers to invest in the region. Manufacturers, however, are obliged to obtain market authorizations from the Food and Drug Authority Ghana, the agency which controls registrations and licenses. The complex Regulatory documentation and critical Regulatory requirements might challenge foreign manufacturers to cope up with the Ghana market authorizations.

Overview

With an outlook of developing economy and efficient Regulatory framework, the Federal Democratic Republic of Ethiopia stands a good opportunity for multinational drug makers. Prior to market entry, drug makers must obtain necessary authorizations from the Food, Medicine and Health Care Administration and Control Authority (FMHACA), the agency which controls the drugs, medical supplies and instruments under the purview of Ministry of Health, Ethiopia.

Overview

Accounting from the recent liberalization, the North African country, Algeria has seen a steady growth in international and private pharmaceutical investments attracting medicine’s and medical device’s investors from all over the world. The Directorate of Pharmacy and Medicine oversee the registrations and licensing management for market access. However, lack of regional Regulatory expertise might challenge foreign manufacturer’s compliance efforts in the region.

Overview

Being reliant on the pharmaceutical imports to encourage the free market competition, Qatar offers good market opportunities for medicinal products and medical devices manufacturers. To enter the region, manufacturers must obtain authorizations from the Ministry of Public Health, Pharmacy and Drug Control Department. However, entering the region challenges the manufacturers with complex Regulatory regime of Qatar.

Overview

With Its rapidly growing economy, Nigeria has been a desirable emerging market for investors. With medical devices and pharmaceutical markets in Nigeria are expected to grow in coming years, foreign manufacturers shall consider quickly initiating their efforts for obtaining market access. Under the Nigerian Federal Ministry of Health, the National Agency for Food and Drugs Administration and Control (NAFDAC) and the Pharmaceutical Council of Nigeria oversees the drug and device regulations in the region.

Overview

Evolving Government healthcare initiatives and quick market expansion establishes positive signs for foreign medicinal product and medical device manufacturers to invest in the Kingdom of Morocco. Under the Ministry of Health (Ministère de la santé, MoH), the Moroccan government regulates the healthcare system inclusive of pharmaceuticals and medical devices.

Overview

With its central location, Tunisia stands as a gateway to Africa offering best business expansion opportunities for foreign medicine and medical device (MD) manufacturers. In addition to the rapidly developed private health care sector investments, Tunisia is leading the race to be the regional medical centre. To enter the region, manufacturers require to obtain the Authorization for Market Commercialization (AMC) from the Directorate of Pharmacy and Pharmaceuticals (DPM) of the Republic of Tunisia.

Overview

Clear-cut Regulatory guidelines coupled with constantly growing economy makes the United Arab Emirates (UAE) a favorable destination for foreign medicinal products & medical device manufacturers who are willing to enter the region. The Ministry of Health regulates the importation of medical devices and medicinal products. It can sometimes be difficult for foreign manufacturers to navigate through various Regulatory approvals required for importation which results in lengthy and complex procedural challenges.

Overview

In recent years, Kenya’s pharmaceutical imports have been growing steadily offering a good scope for drug, food supplement, biopharmaceutical, veterinary products, traditional and complementary medicine manufacturers. Though wide range of business opportunities anticipated, manufacturers might face procedural challenges while navigating through the regulations imposed by Pharmacy and Poisons Board (PPB) – the agency responsible for overseeing the trade in pharmaceutical products.

Overview

Obtaining market approvals in Egypt would require compliance with the regulations of Central Administration of Pharmaceutical Affairs (CAPA), a division of the Egyptian Ministry of Health. To navigate through the registration and approval procedures, manufacturers should require an authorized representative in the region besides being updated with the region’s Regulatory requirements.

Freyr’s Regulatory consulting for Egypt includes strategic advice on Regulatory submissions for: