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(2014; 141 pages)
EFMHACA would like to acknowledge the United States Agency for International Development (USAID) and the U. S. Pharmacopeial Convention Promoting the Quality of Medicines (PQM) Program for the financial and technical support delivered in preparation of this Guidance.
This Guideline succeeds and supersedes the 2008 Guideline, which was in use for drug approval and registration. It is prepared with the same purpose: to inform manufacturers of what documentation should be submitted with requests for approval and registration of pharmaceutical products.
The Guideline provides recommendations on the quality, safety and efficacy information for both active pharmaceutical ingredients (API) and finished pharmaceutical products (FPP) that should be submitted to support product dossiers (PDs) for the registration of medicines in Ethiopia.
The Guideline apply to PDs for products containing an API of synthetic, semi-synthetic, or biotechnological origin; an API that has been previously authorized through a finished pharmaceutical product (FPP) by a stringent regulatory authority; and/or an API or its finished formulation officially included in a pharmacopoeia. APIs from fermentation, biological, or herbal origin are covered by other guidelines. In situations where this Guideline does not address the documentation requirement of a particular application, the matter shall be resolved on a case-by-case basis in consultation with the Authority.