This scoping review included primary research, both qualitative and quantitative, that described interventions or strategies to strengthen pharmacovigilance (PV) capacity, as well as policy and guideline papers from national regulatory authorities (NRA). An initial limited search of MEDLINE, EMBASE, Epistemonikos, Joanna Briggs Institute (JBI) Database of Systematic Reviews and Implementation Reports and Web of Science was undertaken to identify articles of interest. This search strategy was defined in MEDLINE and was adapted for each database above using the Polyglot Search Translator. The search was performed on 25 Jan 2021 in the following databases: Ovid Medline, Ovid Embase, CINAHL via Ebsco, Web of Science core Collection, PDQ Evidence. Sources of grey literature included Google Scholar, websites of technical agencies such as WHO, and websites of selected NRA. A simpler search strategy was defined.

Identified citations from the searches were collated and uploaded into EndNote X9.3 (Clarivate Analytics, PA, USA) and duplicates removed. Three batches of 100 titles and abstracts were tested until two reviewers agreed on the selection. Two batches of 10 full-text articles were tested until agreement on article selection. The results of the search and the study inclusion process were reported in full and presented in a Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping review (PRISMA-ScR) flow diagram (Figure 1: Prisma flow diagram – selection of relevant records).

Abstracts of articles were selected if they met the following inclusion criteria:

• Peer-reviewed papers, and policy papers within the last 30 years (1990 to 2021) that described strategies and intervention to establish or strengthen national PV systems in LMIC
•  Papers describing the capacity of national PV systems if these included interventions to develop PV
•  Articles that described national PV systems and governance

Data were extracted using a data extraction tool developed for the purpose by the reviewers. Extraction parameters included the author, country, year of publication, objective of the research, nature and description of the intervention, the outcome, the challenges encountered and the lessons learnt. The extracted data were presented in a descriptive summary aligned with the objectives of the review. 

Articles were further divided into two categories:

1) Articles describing interventions aimed at increasing pharmacovigilance knowledge and reporting of adverse events.

2) Articles that described interventions aimed at building or strengthening various components of the national PV system.