USAID MTaPS and PQM+ Programs have published a report on ‘Pathway to Digitalize Regulatory Information Management Systems for National Medicines Regulatory Authorities in Low- and Middle-Income Countries’ in 2022.

The report identified  Minimum common standards for RIMS, prerequisites, aspects to consider during implementation, as well as consideration for maintenance and sustainability. It also proposed a rpid assessment questionnaire.

USAIDs also developed OpenRIMS, an open source web-based workflow design module intended to help NRAs digitalize and automate their work processes including but not limited to medicines registration, pharmacy registration, inspection, import/export licensing and clinical trial applications. A pharmacovigilance module was also developed.

USAID’s MTaPS and PQM+ Programs in consultation with key stakeholders established a repository of minimum common standards (MCS) for RIMS for consideration by NRAs to address the identified challenges. Following discussions with SEARN, the ASEAN CTD was added to the list as a basis for future discussions:

November 2024 workshop

As part of the SEARN work plan, USAID’s MTaPS and PQM+ organized on 25-26 November 2024 a 2-day virtual workshop to discuss the minimum common standards for regulatory information management system (RIMS), share country, regional and partner experiences implementing RIMS and develop a regional action plan for the adoption of RIMS by SEARN member states.

Specific objectives were

1. To build knowledge on and discuss minimum common standards for regulatory information management system
2. Provide a platform for NRAs to share their experiences (i.e., strategies, achievements, constraints, and challenges) on RIMS
3. To support the development of a regional action plan for adopting common standards for RIMS for implementation among the member states
4. Develop prioritized recommendations for activities that SEARN and partners (including USAID) could support ‎in the future to promote the implementation of MCS for RIMS aligned with the regional action plan.

To support the discussions, presentations were made by select SEARN member states, USAID MTaPS, USAID PQM+, AUDA-NEPAD and WHO. USAID MTAPS and PQM+ presented and oriented member states on the concept of minimum common standard for regulatory information management system, highlighted the adaptation and Implementation of RIMS Standards and shared experiences on digitalization and Information sharing for regional reliance.

The proposed common standards were mapped against the Global Benchmarking Tool and the SEARN workplan to facilitate future reference.

Recommendations to SEARN included:

• Consider the minimum common standards in its different activities
• Prioritize some domain / activities of interest to SEARN, the associated standards, provide more in-depth information about those and develop a convergence strategy.
• Further consider global digital health guidelines and the experience from AUDA-NEPAD in the development of the regional strategy

A survey was conducted to provide an overview on existing RIMS and needs in the region.

Highlights:

• Two-third of the respondents indicated that there NRA use RIMS, the remaining third did not.
• The use of RIMS was most common for Marketing authorizations, licensing establishments and market control and surveillance.
  • Most respondents indicated that their needs are well covered for marketing authorizations, and licensing establishments. The situation seemed least satisfactory with clinical trials, lot release and vigilance.
  • However, responses suggested SEARN members would still prioritize Marketing authorization, in addition to market control, vigilance and laboratory testing for further development of RIMS.
  • For convergence/harmonization of standards, SEARN members would prioritize marketing authorizations, followed by Regulatory inspections.
• Compliance with common standards appeared quite low, except INN and ATC for data dictionaries, and PDF, CTD and ASEAN CTD for Data Exchange Standards.
• NRAs all indicated having access to an IT department (either from NRA or MoH), which usually support the maintenance of existing RIMS but cannot support its development.
• A number of challenges were identified:
  • The main quoted challenges to the development of RIMS were funding and technical support, followed by Staff IT fluency and Network speed.
  • While access to desktop/laptop appears satisfactory, often over 75%, there is no computer network in two NRAs and staff IT proficiency appeared to be a common issue, with 6 NRAs indicating less than 75% IT proficient staff. However, respondents indicated the staff has usually received training for the specific RIMS in use.
  • While RIMS usually enable information sharing with stakeholders, these have not developed to enable information sharing between NRAs
  • When using several RIMS, these are most of the time not interoperable.
  • Existing RIMS commonly do not enable NRAs to effectively monitor KPIS
• The following good practices / lessons learned were highlighted by respondents:
  • The criticality of clear requirements in the pre-development phase, tailored approach, and engagement of local developers
  • Gradual implementation was reported as a key factor for smooth integration and adaptation, as well as early stakeholders engagement
  • The importance of integration with other national systems (e.g. tax, customs) and enabling real-time monitoring of KPI were highlighted
  • The use of digital signatures was also seen as an important enabler.
  • Challenges for future development included cyber threats, use of AI, automatic pre-screening of applications, and integration of systems from different parties.
  • One member recommended for SEARN regional knowledge-sharing, standardized yet flexible frameworks, and capacity-building to enhance RIMS development.