Pharmaceutical Regulatory Affairs

Biography

Biography: Solomon Getnet Meshesha

Abstract

Issues related to the quality of medicines are becoming an increasing global concern especially in developing countries. Achieving a high level of quality requires effective medicine legislation and regulation, a competent medicines regulatory authority, good clinical and manufacturing practices with adequate medicines, quality assurance programs and medicines, quality control systems and appropriate medicines information. A qualitative study design was used to obtain primary and secondary information through interviewing key informants and reviewing all available relevant documents from the Addis Ababa city administration medicine regulatory and control authority. Addis Abba medicine regulatory authority is an independent organization whose top management committed to implement quality management and data on licensed and resisted health facilities and professionals are up to date but the authority has no policy on confidentiality and code of conduct for staff s, guideline to ensure requirements on quality, safety and efficacy of drugs and also mechanism to trace any counterfeit and substandard drugs. It has no any scientific body (laboratories) to advise the organization on scientific issues. The regulatory authority was an independent authority established to ensure food safety and quality, efficacy and proper use of medicines, competence and ethics of health professionals and standards of health institutions through licensing, registration and regulations against the set standards. The authority has to keep those findings as strength of the organization and much has to be done to meet the authority’s goals and objectives.