Jun 23, 2022 | Basic page
List of Selected Indicators
| Category | Category 1: Policy, Strategy and Legal Framework |
| Indicator | Existence of National Medicines Policy (NMP) |
| Sub Indicator | Does NMRA have a National Medicines Policy (NMP) |
| Sub Indicator | Does the NMP provide for regional cooperation and harmonisation |
| Sub Indicator | Has the NMP been reviewed within the past 5 years? |
| Sub Indicator | Do you have an Institutional Development Plan |
| Indicator | Availability of Legal Framework Governing the Regulation of Medical Products |
| Sub Indicator | Do you have a Law for regulating medicine in your country |
| Category | Category 2: NMRA Governance |
| Indicator | Level of autonomy of the NMRA |
| Sub Indicator | Is the NMRA autonomous according to AU model law (rating autonomous or semi autonomous or department under the Ministry of Health) |
| Category | CATEGORY 4: MEDICINES EVALUATION AND REGISTRATION, AND GOOD MANUFACTURING PRACTICE (GMP) INSPECTION SYSTEMS |
| Indicator | Marketing Authorisation and Registration |
| Sub Indicator | NMRA has been benchmarked using WHO GBT |
| Sub Indicator | According to WHO GBT, Marketing Authorisation and Registration function is established and operating at what maturity level? |
| Sub Indicator | Has the NMRA adopted any of the following African Medicines Regulatory Harmonization (AMRH) continental technical guidelines |
| Sub Indicator | Has the NMRA used regional recommendations on joint assessment for the reporting period? |
| Indicator | Number of product applications with registration decisions for 2021 |
| Sub Indicator | Number of products registered based on Regional Joint Review in the year 2021 |
| Sub Indicator | Is the NMRA utilizing the reliance models for marketing authorisation (MA) decisions |
| Sub Indicator | If your response to question above was YES, please indicate if the following regulatory pathways are used as reference standard |
| Indicator | NMRAs participation in joint assessments for 2021 |
| Sub Indicator | NMRA participating in regional joint assessments |
| Sub Indicator | Has the NMRA used regional recommendations on joint inspection of manufacturing site for the reporting period |
| Sub Indicator | Is the NMRA utilizing any reliance models for GMP inspection such as desk document review |
| Sub Indicator | NMRA has been assessed using WHO GBT |
| Sub Indicator | According to WHO GBT, GMP inspection function is established and operating at maturity level? |
| Sub Indicator | Does NMRA use all regional harmonized guidelines for GMP inspection |
| Sub Indicator | Number of GMP inspection decisions made based on document review/ inspection report in the year 2021 |
| Category | CATEGORY 5: FUNCTIONAL QUALITY MANAGEMENT SYSTEMS (QMS) |
| Indicator | Implementation of Quality Management System (QMS) requirements by NMRA |
| Sub Indicator | NMRA ISO 9001: 2015 QMS certified |
| Category | CATEGORY 6: INFORMATION MANAGEMENT SYSTEMS (IMS) |
| Indicator | Implementation of requirements for an integrated IMS |
| Sub Indicator | Implementation of IMS modules by NMRA (MA, CT, PV, RI, MD) |
| Category | CATEGORY 7: TRANSPARENCY, ACCOUNTABILITY AND COMMUNICATION |
| Indicator | Communication and Information Sharing |
| Sub Indicator | NMRA sharing regulatory information with others in the REC region |
| Sub Indicator | NMRA IMS linked to other NMRAs in the region |
| Sub Indicator | NMRA IMS linked to REC Secretariat |
| Sub Indicator | The NMRA has its own web page with timely information that gives public access to related legal provisions, guidelines, SOPs and decisions. |
| Category | CATEGORY 9: PARTNERSHIPS AND COORDINATION |
| Indicator | Partnership coordination towards collective impact on regulatory systems strengthening and harmonisation |
| Sub Indicator | Availability of mechanism for coordination of partners at country levels |
| Sub Indicator | Partners providing support at country level on various regulatory functions/ mechanisms |
