Harmonizing standards for regulatory information management systems

Harmonizing standards for regulatory information management systems  

Regulatory information management systems (RIMS) are key to ensuring access to safe, effective, and quality-assured medical products. Yet, in many low- and middle-income countries, RIMS don’t exist or function properly, are disjointed or poorly managed, or can’t operate with other systems in or between countries.

Adopting common RIMS standards would help regulators share real-time data, expedite product assessments and facility inspections, and conduct more efficient operations.

Countries consider minimum standardswoman reading binders

Funded by the U.S. Agency for International Development (USAID), the Promoting the Quality of Medicines Plus (PQM+) program and Medicines, Technologies, and Pharmaceutical Services (MTaPS) program developed a series of reports to harmonize standards for RIMS.

When regulators lack access to data on product quality, their ability to make informed public health decisions decreases, and delays in registration times for new products increases.

Many national regulators struggle to fully operationalize both web- and paper-based RIMS, which limits the availability of timely data. But by developing a set of minimum common standards, national regulators may streamline workflows and regulatory processes, ensure uniform data capture, and enable accurate and timely data exchange, and accelerate access to quality-assured medicines. For more information, download the full consultative process.

Read the advocacy brief

Read the report

Read the blog

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