Strong regulatory systems are fundamental to assuring the quality, safety, and efficacy of medical products worldwide. Yet, many low- and middle-income countries lack stable and well-functioning regulatory systems, which put communities at risk of receiving poor quality medicines.
We partner with regional and national regulatory authorities, national control laboratories, academic institutions, and other international organizations to develop tailored strategies to increase regulatory capacity and strengthen regulatory functions, including improving product registration, facility inspections, risk-based post-marketing surveillance, work force capabilities, and more.
Resources
- Mali strengthens surveillance of medical products (August 2023)
- Pakistan improves vaccine safety monitoring (April 2023)
- Uzbekistan streamlines TB medicine registration (March 2023)
- Ghana FDA uses risk-based surveillance to ensure quality medical products (September 2023)
- Emergency use authorizations for therapeutics: Guidance for national medicine regulatory authorities (December 2023)
- Facilitated regulatory pathways model dossier (December 2023)
- Test-to-Treat resource: Scientific and technical information on COVID-19 therapeutics (September 2023)
- Press release: USAID provides $7.1 million to USP to build trust in the supply of vaccines through PQM+ (August 2022)
- Report: Harmonizing standards for regulatory information management systems (RIMS) (November 2022)
- Risk-based post-marketing surveillance of medicines: Implementation resources for low- and middle-income countries (PDF, EN, ES) (October 2021)
