Table 1 Indicators Matrix
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 |