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

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

Country	Date of assessment	Policy, year of reinforcement(year of last update)			Proclamation/ Act		Regulations		Guidelines
Country	Date of assessment	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	NA^a	Medicines & RelatedSubstances ControlAct (Act no. 9), 2016	No	NA	NA	NA	NA^c
Ethiopia	27–31 Aug 2018	1993 (2000)^a	1993 (2000)^din Health Policy	NA	ProclamationNo. 661/2009	Yes	No. 299/2013^a, 2013	Yes	ADR Guideline, 2018Guideline for AdverseDrug EventsMonitoring[Pharmacovigilance],2018	NA^c
Nigeria	24–28 Sept 2018	2004 (NA)	2003 (2005)	2012^a	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	NA^c

^a(update) expected in 2019/2020
^bIn Eswatini, there is a National Pharmacy Policy, not a National drug policy
^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
^dincluded in National Health Policy

ISSN: 1472-6963