Regulatory Systems Assessments in Selected Low-and Middle-income Countries (LMICs)


Wed, Jun 26 11:45AM
W 32


Regulatory Systems Assessments in Selected Low-and Middle-income Countries (LMICs)

Abstract Summary

U.S. Agency for International Development (USAID)-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) and its predecessor Strengthening Pharmaceutical System (SPS) programs used the Regulatory Systems Assessment Tool (RSAT) to conduct structured assessments in Angola, Bangladesh, Guinea, Mozambique, Namibia, and Democratic Republic of Congo (DRC) from 2009 to 2012. The excel-based tool was developed through the adaptation of existing assessment tools including World Health Organization (WHO) national regulatory system assessment tool, WHO Good Governance for Medicines, United States Pharmacopoeia (USP) rapid assessment of quality assurance and quality control of medicines, and SPS indicator-based pharmacovigilance assessment tool. Components of RSAT include background information on the pharmaceutical sector, regulatory framework, regulatory functions and processes, and monitoring evaluation. The tool enables analysis of options towards reform of regulatory systems to improve efficiency and timely access to health products. The assessment involved reviews of relevant policies, laws, regulations and guidance documents, analysis of regulatory processes, and interviews with key informants at the Ministries of Health (MoH) and MRAs.

Poster Presenter

Hye Lynn Choi
Technical Advisor,
Management Sciences For Health
United States

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