Harmonizing Standards for Regulatory Information Management Systems
E-DRUG: Harmonizing Standards for Regulatory Information Management Systems
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National medical regulatory authorities (NMRAs) in most low- and middle-income countries suffer from disjointed or poorly managed regulatory information management systems (RIMS) or are paper based, which limits their ability to efficiently make regulatory decisions and bring quality, safe, and effective medical products to market.
To help harmonize these systems and speed access to quality-assured medical products, USAID's Medicines, Technologies, and Pharmaceutical Services (MTaPS) and Promoting the Quality of Medicines Plus (PQM+) programs conducted a series of consultations with 14 NMRAs and 17 global/regional regulatory agencies to identify and recommend a set of 32 minimum common standards.
The proposed RIMS standards would:
-support uniform data capture;
-standardize data, design, and workflow of digitalized regulatory functions; and
-facilitate communication among NMRA departments and stakeholders.
Read about the initiative in a new joint blog:
Finding Common Ground: Transforming Regulatory Information Systems in LMICs
https://www.mtapsprogram.org/news-blog/finding-common-ground-transforming-regulatory-information-management-systems-in-low-and-middle-income-countries/
Access the resulting resources - a summary report, guidance document, and Call to Action:
Rajita Majumdar
USAID MTaPS Strategic Communications Lead
Management Sciences for Health
Stronger health systems. Greater health impact.
"Majumdar,Rajita" <rmajumdar@mtapsprogram.org>