The CIOMS V Working Group (WG) met in a series of 8 formal meetings during the years 1997 to 2000. The printed version of their report ”Current Challenges in Pharmacovigilance: Pragmatic Approaches” was published in 2001. The CIOMS WG V, through its report, advocated acceptance for a wide range of proposals concerning issues covering terminology and definitions, common every day practices such as follow-up of individual adverse events, the rational scheduling and content of periodic safety update reports (PSURs), the role of internet and quantification of population drug use. The completed report, intended as a handbook for pharmacovigilance departments and still offering many pragmatic solutions to a number of issues, has been in great demand. CIOMS has now decided to make the publication available free of charge to download on its website.