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Table 2 Legal provisions for pharmacovigilance in four Sub-Saharan African countries, 2018

From: Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis

Country Date of assessment Policy, year of reinforcement(year of last update) Proclamation/ Act Regulations Guidelines
Nationalhealthpolicy Nationaldrugpolicy StandalonePV policy title and/ ornumber, year legal provisionsfor PV? title and/ ornumber, year legal provisionsfor PV? General PV guidelines For aDSMspecifically
Eswatini 25–29 Jun 2018 2006 (2011) 2011 (NA)b NAa Medicines & RelatedSubstances ControlAct (Act no. 9), 2016 No NA NA NA NAc
Ethiopia 27–31 Aug 2018 1993 (2000)a 1993 (2000)din Health Policy NA ProclamationNo. 661/2009 Yes No. 299/2013a, 2013 Yes ADR Guideline, 2018Guideline for AdverseDrug EventsMonitoring[Pharmacovigilance],2018 NAc
Nigeria 24–28 Sept 2018 2004 (NA) 2003 (2005) 2012a Decree 15, 1993 Nowreferred to as ActCap N1 Laws of theFederal Republic ofNigeria, 2004 Yes National PVimplementationframework No NAFDAC GoodPharmacovigilancePractice Guidelines,2016 2018
Tanzania 30 Jul-5 Aug 2018 2007 (NA) 1991 (2007) 2018 Medicines andMedical Devices Act,Cap 219, 2003 Yes Pharmacovigilanceregulations, 2018 Yes National Guidelines forMonitoring MedicinesSafety, 2018 NAc
  1. a(update) expected in 2019/2020
  2. bIn Eswatini, there is a National Pharmacy Policy, not a National drug policy
  3. cFor Eswatini, there is a very short section about aDSM in the national guidelines “Bedaquiline and Delamanid for the Treatment of Drug Resistant Tuberculosis: Guidelines for Clinicians” (SIAPS, 2015), for Ethiopia, a section is included in the National Guideline for drug-resistant tuberculosis (NTP, 2018, 2nd edition), for Tanzania, there is a training manual on aDSM, which does put focus on the management of aDSM rather than the reporting of ADR
  4. dincluded in National Health Policy