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 provide 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. Through the International Conference on Harmonization (ICH) process, the Quality Module of the Common Technical Document (CTD) provides considerable harmonization of organization and format for registration documents. This recommended format in the M4Q, M4S, and M4E Guidelines for the quality, safety and efficacy information of registration applications have become widely accepted by regulatory authorities both within and beyond the ICH regions. To facilitate the preparation of the PD, this Guideline is organized in accordance with the structure of the Common Technical Document – Quality (M4Q), Safety (M4S), and Efficacy (M4E) Guidelines developed by ICH, and also with the WHO Guideline for submission of documents for multisource and innovator finished pharmaceutical products. Applicants are advised to read and understand the contents of this Guideline and the instructions given under the ―General Guidance and Format‖ before submitting a dossier to the Authority. Once a product is registered, its registration is valid for four years only. It is, therefore, mandatory for manufacturers to apply for re-registration by submitting the required information before the due date as described in Appendix 4 of this Guideline. Any variation to a registered medicine should be addressed as described in the ―Guideline for Variation Application.