OBJECTIVES: Multiple sclerosis (MS) is an autoimmune and inflammatory demyelinating disease of the central nervous system, often characterized by relapsing episodes of neurologic impairment followed by remissions (relapsing remitting MS). In about a third of MS patients, the disease evolves into a progressive course (progressive MS). The objective of this study was to evaluate how health-related quality of life (HRQL) was taken into consideration in the evaluation of MS products approved by the FDA and the EMA since 1995. METHODS: The websites of the FDA and the EMA were explored to identify all MS products approved. All labels and corresponding clinical reviews (FDA), summary of product characteristics (SmPC) and assessments reports (EMA) were manually retrieved and reviewed for HRQL evaluation. RESULTS: Twelve different products (11 INN) were approved: nine by both agencies, one only by the EMA, and two only by the FDA. For the products approved by both agencies, the same clinical studies were submitted. HRQL was evaluated in seven products. In only one case, HRQL evaluation was mentioned, i.e., in the SmPC of interferon beta-1b (“No benefit, attributable to […] in quality of life (as measured by FAMS – Functional Assessment of MS: Treatment Outcomes Index) was seen”). There was no HRQL mention in the corresponding FDA label for the same product. In four products HRQL was evaluated with generic measures (e.g., SF-36 or SF-12). In most cases, it was considered as a tertiary /exploratory endpoint. In three products (alemtuzumab, natalizumab, and teriflunomide), statistical differences in HRQL endpoints were seen (measured by the FAMS and/or the SF-36), but not reported in labels/SmPCs. CONCLUSIONS: HRQL is not considered as a key endpoint in the evaluation of MS products. A patient-focused drug development initiative in MS could be helpful to enhance development and use of HRQL MS-specific measures in clinical trials.