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Table 1 Indicators Matrix

From: Harmonization of medical products regulation: a key factor for improving regulatory capacity in the East African Community

  Indicator Title Type Reporting Level Frequency Data Sources
Category 1 Policy and legal framework
Indicator 1 National Medicines Policy (NMP) Input NMRA Three yearly WHO NMRA GBT, Government gazette, Ministry of Health
Indicator 2 Legal framework governing the regulation of medical products Input NMRA Three yearly WHO NMRA GBT, Government Gazette, National Law, Ministry of Justice library, NMRA records
Category 2 NMRA governance
Indicator 3 NMRA level of autonomy Output NMRA Three yearly WHO NMRA GBT, CIRS OpERA programme, Government gazette, NMRA Financial report, Governance structure
Indicator 4 Availability of structures to support NMRA decision making process Process NMRA Three yearly NMRA Organisation/governance structure,
Medicines law
Category 4 Medicines evaluation and registration, and good manufacturing practice (GMP) inspection systems
Indicator 5 Availability of guidance and procedures for registration of medicines Process NMRA Annually WHO NMRA GBT, CIRS OpERA programme, NMRA records, Government policies and legislation
Indicator 6 NMRAs using regionally harmonized guidelines for product registration Output Regional Annually CIRS OpERA programme, NMRA Records; REC Records
Indicator 7 Availability of a process to track product registration applications and timelines Process NMRA Annually WHO NMRA GBT, CIRS OpERA programme, NMRA records
Indicator 8 Number of products applications with registration decisions per annum Outcome Regional Annually CIRS OpERA programme, NMRA records
Indicator 9 Proportion of NMRAs participating in joint assessments Output Regional Annually CIRS OpERA programme, REC records
Indicator 10 Proportion of product applications jointly assessed/ reviewed at regional level Outcome Regional; continental Annually CIRS OpERA programme, REC records
Indicator 11 Availability of a Good Manufacturing Practice (GMP) inspection guidance and procedure Process NMRA Annually WHO NMRA GBT, NMRA records, Government policies and legislation, WHO Assessment Reports
Category 5 Functional Quality Management Systems (QMS)
Indicator 12 Implementation of Quality Management System (QMS) requirements by NMRA Process NMRA; regional Annually CIRS OpERA programme, NMRA QMS Records
Indicator 13 Percentage of NMRAs ISO 9001: 2015 Certification Output NMRA; regional Annually NMRAs QMS Records
Category 6 Information Management Systems (IMS)
Indicator 14 Implementation of requirements for an integrated IMS Output NMRA; regional Annually WHO NMRA GBT, NMRA IMS