All manufacturers intending to export drugs and pharmaceutical products to Ethiopia are required to register with The Drug Administration and Control Authority (DACA) as the regulatory authority of the Government. For registration with DACA, a company should have a WHO-GMP certification. The registration is granted keeping in view the requirements of the Ethiopia’s Essential Drugs List[1].

The regulatory Sector of Ethiopian Food, Medicine and Healthcare Administration and Control Authority is in charge of ensuring the safety, efficacy, quality and proper use of medicines. Thus, it regulates medicines, supplies, medical equipment, and biologicals through laws and regulations.

As a signatory of Multilateral Investment Guarantee Agency (MIGA), Ethiopia also concludes the Bilateral Investment Promotion and Protection Treaties with 30 countries and the Double Taxation Avoidance Treaties with 18 countries. Together with The Ethiopia Constitution and the Investment Law, Ethiopia guarantees foreign investors against nationalization or expropriation.

Foreign investors also have the right to full repatriation of profits, dividends, principal and interest payments on external loan, etc. out of Ethiopia in convertible currency at the prevailing rate of exchange. Employing expatriate managers and experts is also the basic right for foreign investors.

1) Laws: At legal framework’s level, the medicine shall only be produced locally or imported and put in use after it is duly registered by the executive organ after being tested for its safety, efficacy and quality. The certificate of registration of a medicine shall be renewed every four years where the medicine continues to meet the requirements of registration. Any medicine manufacturer or agent may only manufacture or import a medicine that is included in the national drug list. The authority shall issue certificate of registration of market authorization after assuring compliance to GMP, medicine dossier’s evaluation and fulfillment of safety, efficacy and quality requirements, and fulfillment of laboratory quality test requirements.

2) Regulations: For the registration and quality assurance, the medicine need to take and pass remarket testing, consignment testing, and sample from market testing. No medicine is allowed to enter to Ethiopia without the prior permission of the Authority. The Authority may grant a special permit for the import of medicine that not registered for some circumstances. The current registration system is based on registration guideline with Common Technical Document format. For companies approved by stringent regulatory authorities, the registration process will be expedited. And the Authority provides fast track registration process, approximately 30 days, for locally manufactured medicines, HIV, tuberculosis, malaria, and reproductive health products, which is a great incentive compared with around 1.5-2 years for import medicines. Besides, 15% of the government procurement must spend on local products.

[1] Ibid., p.9.