Juvenile idiopathic arthritis (JIA) is a heterogenous group of conditions, defined as arthritis persisting for 6 weeks or longer with no other identifiable cause and onset prior to age 16. JIA is the most common pediatric rheumatic illness, with an annual incidence in developed countries of 2 to 20 per 100,000 children and a prevalence of 16 to 150 per 100,000. Tofacitinib (Xeljanz®) is an oral Janus Kinase (JAK) inhibitor approved in the European Union (EU) in adult populations for the treatment of moderate to severe rheumatoid arthritis (RA), active PsA, and moderate to severe ulcerative colitis (UC). The important identified and potential risks associated with use of tofacitinib listed in the Risk Management Plan (RMP) include (but not limited to): venous thromboembolism, serious infections (including tuberculosis),herpes zoster or HZ, fractures, malignancy excluding NMSC, NMSC, lymphoma, lung cancer, all-cause mortality, interstitial lung disease, gastrointestinal perforations, PML, myocardial infarction (MI), and cardiovascular risk (excluding MI). Within the JIA population, additional events of interest include growth or developmentdisturbances and response to vaccination. Furthermore, drug hypersensitivity is considered as an identified risk and listed in the Summary of Product Characteristics (SmPC), but does not meet the criteria to be included in the RMP. As part of the tofacitinib pharmacovigilance plan, Pfizer will implement a post-approval, active surveillance study of patients with pJIA or juvenile PsA initiating tofacitinib and those treated with approved bDMARDs using prospectively collected data included in nationwide Swedish healthcare registers to actively monitor the safety events of interest in the post-approval real-world setting, including events associated with long-term use.