Table 2.

Inclusion and exclusion criteria

	Inclusion criteria	Exclusion criteria
Setting	Developing countries
Species	Human	Animal
Location	International
Language	English
Design/Study type	Qualitative and quantitative studies. Randomised control trials (RCTs) with a primary component related to the evaluation or assessment of pharmacovigilance systems or activities	All types of reviews. Randomised control trials (RCTs) with no secondary aim related to the evaluation of pharmacovigilance systems or activities
Publication type	Full-text peer-reviewed journal studies based on empirical research or with a clear empirical base	Non-peer-reviewed studies and conference abstracts, case reports, editorials, opinion pieces, commentaries and conceptual studies
Publication date	2012–2021
Focus of study	Studies about the characteristics, performance metrics, or effectiveness of pharmacovigilance system(s) at some level. e.g. PV centre (national or peripheral), healthcare facilities (hospitals or clinics), Public Healthcare Programmes (PHP), or pharmaceutical companies within a developing country	∙ Studies focussing on non-medication related adverse events (e.g. surgical adverse events), allergies, medication errors, abuse or misuse, medical devices, veterinary products, traditional or complementary medicines, vaccines, food supplements
		∙ ADR-reporting systems based on computerised physician order entry systems, electronic medical records and registries specific to one drug or disease
		∙ Studies of pharmacodynamic, pharmacokinetic and pharmacogenetic measures