MAJOR REGULATORY REFORM IN ETHIOPIA'S HEALTHCARE SECTOR: EFDA Issues New Rational Medicine Use Control Directive No. 1138/2026

The new directive establishes a significantly enhanced regulatory framework governing the prescribing, dispensing, compounding, monitoring, and promotion of medicines in Ethiopia. The reform reflects the evolving needs of the healthcare sector and introduces measures designed to improve patient safety, strengthen accountability among healthcare professionals, support the digitalization of healthcare services, and address the growing global challenge of antimicrobial resistance.

The directive represents one of the most comprehensive updates to Ethiopia’s medicine-use regulatory framework in recent years and will require healthcare institutions and professionals to review their existing policies, procedures, and operational practices to ensure compliance.

The new directive introduces a more comprehensive and detailed approach to the regulation of medicine use. Several definitions and regulatory concepts have been updated to align with current healthcare practices and international standards.

Important concepts such as antimicrobial resistance, trade names, and transcription papers have been expressly defined, while the qualifications and licensing requirements of healthcare professionals are articulated with greater clarity. These updates provide improved legal certainty and facilitate more consistent implementation across healthcare institutions. Please read the full details in the attachment.