Strengthening Regulatory Systems

In low- and middle-income countries, regulatory authorities often face challenges in ensuring that medicines are manufactured, imported, stored, distributed, and used according to quality standards. This ultimately affects their ability to fulfill their essential functions of protecting people and promoting public health.

Our Approach

USP works with National Medicines Regulatory Authorities (NMRAs) to strengthen the building blocks of effective regulatory systems to develop capacity and effectively utilize public quality standards. We provide technical assistance to NMRAs and official medicines control laboratories to develop capacity in medicines evaluation, inspection, and quality surveillance.

Areas of Technical Support & Training

    Regulatory System Strengthening
    • Policy, legislation, and regulation
    • Guidelines, procedures, and specifications
    • Pharmaceutical sector inspection, including cGMP inspection
    • Dossier review and evaluation
    • Medicines registration, marketing authorization, and licensing
    • Data standards and regulatory information management
    • Quality/post marketing surveillance
    Laboratory Quality Management System Strengthening
    • Quality assurance
    • Quality control
    • Good Laboratory and Good Documentation Practices
    • Audits and corrective and preventive action plans
    • ISO accreditation and WHO prequalification
    Analytical and Consultative Support
    • Quality control
    • Quality detection tools and field-based screening technologies