Finding Common Ground: Transforming Regulatory Information Management Systems in Low- and Middle-Income Countries

By Margareth Ndomondo-Sigonda (AUDA-NEPAD), Abdul Mughees Muddassir (Drug Regulatory Authority of Pakistan), Shafia Rashid (MTaPS), Kate Kikule (MTaPS), Maura Brown (MTaPS), Gabriel Kaddu (PQM+), Souly Phanouvong (PQM+) 

Making progress toward achieving universal health coverage (UHC) and Sustainable Development Goal 3.8 (ensure “access to safe, effective, quality, and affordable essential medicines and vaccines for all”) requires concerted action from national, regional, and global stakeholders. Achieving these goals depends in part on strengthening national medicines regulatory authorities to ensure the quality, safety, and efficacy of medical products circulating in the market, which will contribute to improving the quality of health services and ensuring positive health outcomes.

National regulatory authorities are faced with multiple challenges in carrying out their core functions: large volumes of sensitive and scientifically complex data to process and manage and reliance on paper-based, inadequately designed, poorly functioning, and/or non-interoperable information management systems that do not meet their modern regulatory needs. This can result in inefficient workflows and unnecessary duplication of effort, ineffective communication, lack of transparency, mismanagement, and vulnerability to corruption.

Developing Common Standards for Regulatory Information Management Systems

Two years ago, the USAID MTaPS and Promoting Quality of Medicines Plus (PQM+) programs began collaborating with a range of stakeholders to identify—as a foundational element—the common standards appropriate for integrated and interoperable regulatory information management systems (RIMS). MTaPS and PQM+ convened representatives from 14 national regulatory authorities and 17 global/regional regulatory agencies and funding agencies to develop a set of minimum common standards upon which all regulatory information management systems should be based. Adopting the set of minimum common standards within the RIMS will enable regulatory authorities to prioritize and streamline their workflows, maintain appropriate documentation of regulatory processes, ensure uniform data capture, and exchange data within national regulatory systems and between other national regulatory authorities and stakeholders.

The use of common standards increases the likelihood that data are available, valid, and reliable, contributing to consistent, transparent, and informed decision-making based on quality data. When countries use RIMS that are built on identified standards, it can serve as the basis for internal integration of national regulatory functions and harmonizing regulatory processes across regions. This will facilitate reliance and work-sharing, thereby offering much-needed improvement in regulatory efficiency and speeding market access for lifesaving medical products in resource-constrained settings.

Outcomes from the Consultative Process

As outlined in the report on the consultative process with national regulatory authorities and other expert stakeholders, key outcomes from the discussions include:

• Identification of the critical gaps and challenges with RIMS faced by national regulatory authorities and other stakeholders
• A recommended set of minimum common standards for RIMS that address identified gaps and challenges. A total of 56 standards were collated and classified into three categories:

– Process standard

– Pharmaceutical standard dictionaries and knowledge trees

– Data exchange standards

• An advocacy brief that provides a call to action to global, regional, and national stakeholders for adopting the standards to support RIMS in low- and middle-income countries
• A pathway document that identifies concrete steps and specific considerations for supporting national regulatory authorities to digitalize their information management systems

Access the above RIMS resources 

What are the benefits of adopting common standards for regulatory information management systems?

• More efficient operations
• Expedited product assessments and facility inspections
• Easy information sharing, especially among harmonization initiatives
• Interoperability with international systems
• Common language for system design

What’s Next

With the minimum common standards now identified, global, regional, and national stakeholders can take steps to adopt them—taking into account the available financial and human resources, infrastructure, and the regulatory system’s maturity level.

National regulatory authorities should set a policy to adopt and integrate the standards in the RIMS and to incorporate the minimum standards in the software system specifications as part of the design of RIMS tools.

Global stakeholders and donors, such as USAID; the Bill & Melinda Gates Foundation; the Global Fund to Fight AIDS, Tuberculosis, and Malaria; the World Bank; and the WHO, should provide guidance and support to adopt the standards as countries and regional regulatory entities select and introduce RIMS and formalize reliance/work sharing and harmonization/convergence arrangements. The WHO recognizes the importance of standards-based information management systems that are fit for purpose in promoting the timely capture and exchange of regulatory information and is in the process of developing guidance for establishing electronic information management systems that suit the needs of regulatory authorities across the spectrum of maturity levels, with reference to the set of minimum common standards identified.

At the regional level, regional economic communities, such as the East African Community (EAC), the Intergovernmental Authority on Development (IGAD), the Economic Community of West African States (ECOWAS), the Association of Southeast Asian Nations (ASEAN), and the South-East Asia Regulatory Network (SEARN); and regional health organizations, would benefit from introducing the concept to member states and integrating the minimum common standards into national regulatory authorities’ strategic plans, particularly for promoting convergence and harmonization of medical products regulation.

Finally, national policymakers can take steps to adopt and integrate the standards as part of the transformation of their medicines regulatory information systems, whether they are making incremental upgrades or conducting an overhaul.

Together, these actions will strengthen national regulatory systems to improve access to quality, safe, effective, and affordable medical products and contribute to countries’ efforts to improve pharmaceutical services, putting them on a firm footing to achieve UHC and Sustainable Development Goal 3.8.