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INTRODUCTION: Following the start of the World Health Organization (WHO) Programme for International Drug Monitoring (PIDM) by 10 member countries in 1968, it took another 24 years for the first two African countries to join in 1992, by which time the number of member countries in the PIDM had grown to 33. Whilst pharmacovigilance (PV), including the submission of individual case safety reports (ICSR) to VigiBase(®), the WHO global ICSR database, is growing in Africa, no data have been published on the growth of ICSR reporting from Africa and how the features of ICSRs from Africa compare with the rest of the world (RoW).OBJECTIVE: The objective of this paper was to provide an overview of the growth of national PV centres in Africa, the reporting of ICSRs by African countries, and the features of ICSRs from Africa, and to compare ICSRs from Africa with the RoW.METHODS: The search and analysis interface of VigiBase(®)-VigiLyze(®)-was used to characterise ICSRs submitted by African countries and the RoW. The distribution of ICSRs by African countries was listed and characterised by anatomic therapeutic chemical (ATC) code, Medical Dictionary for Regulatory Activities (MedDRA(®)) system organ class (SOC) classification, and patient age and sex. The case-defining features of ICSRs between Africa and the RoW were also compared.RESULTS: The number of African countries in the PIDM increased from 2 in 1992 to 35 at the end of September 2015, and African PIDM members have cumulatively submitted 103,499 ICSRs (0.88 % of global ICSRs) to VigiBase(®). The main class of products in African ICSRs are nucleoside and nucleotide reverse transcriptase inhibitors (14.04 %), non-nucleoside reverse transcriptase inhibitors (9.09 %), antivirals for the treatment of HIV infections (5.50 %), combinations of sulfonamides and trimethoprim (2.98 %) and angiotensin-converting enzyme (ACE) inhibitors (2.42 %). The main product classes implicated in ICSRs from the RoW are

Background: Drug regulatory science closely relates to pharmacoepidemiology, particularly where epidemiologic methods are used to derive empirical evidence on the outcomes and implications of drug regulation. Objectives: In this symposium, we will present the results from recent regulatory science studies on the functioning of post-marketing surveillance systems. Description: After a short introduction of the scientific field and methods applied to evaluate pharmacovigilance systems, results from four recently performed studies will be presented. The studies cover different aspects from the pharmacovigilance system in different continents: (1) Predictors of successful pharmacovigilance systems in Africa: determinants of ADR reporting in African countries (Hilda Ampadu) (2) FDAAA mandated 18 months, 10 000 patient reviews: experiences with the first cohort of newly approved products in the USA since 2007 (Shohko Sekine) (3) Characteristics and follow-up of post-marketing obligations of medicinal products with a conditional marketing authorization in Europe, 2006- 2014 (Jarno Hoekman) (4) The role of registries in European post-marketing surveillance, a retrospective analysis of centrally approved products, 2005-2013 (Xavier Kurz) A multidisciplinary panel will provide their views and results of the studies. Implications for policy and further research will be discussed with panelists and the broader audience. Three different angles of focus will be chosen. The academic perspective: What are the implications for data collection and methodologies? The regulatory perspective: What are the implications for design and enforcement of post-marketing obligations? The pharmacovigilance perspective: What are the implications for how to organize to post-marketing surveillance in practice?