Supporting Pharmaceutical Regulatory Systems

Weaknesses in pharmaceutical regulatory systems contribute to limited access to quality-assured, safe, and efficacious life-saving essential medicines, including those for malaria; HIV/AIDS; and reproductive, maternal, and childhood diseases, and to the disruption of health service delivery, thereby preventing achievement of better health outcomes.

USAID MTaPS supports LMICs to improve their pharmaceutical regulatory systems, including pharmacovigilance (PV) systems, to deliver safe, effective, and quality assured medicines by:

• Strengthening regulatory capacity and pharmaceutical-sector governance to protect the public from substandard and falsified products
• Promoting transparency and accountability through appropriate laws, regulations, policies, and standard operating procedures
• Improving human and institutional capacity to manage pharmaceutical regulatory systems and services, including protecting patient safety and slowing the emergence and spread of antimicrobial resistance