OBJECTIVES: In public funded health care systems accessibility (time to decision) to new medicines is crucially dependent on the assessment process by the competent Authorities. In Portugal, since 2007, new medicines are explicitly (hospital) or implicitly (ambulatory) assessed (cost and effectiveness) by the Portuguese Ministry of Health (PMH) before they can be purchased (financed) by hospitals or Regional Health Authorities, respectively. This study aimed to measure time to financing decision from the PMH using survival analysis and confront the results to the maximum decision timelines established in the Law: 70 days (hospital) and 110 days (ambulatory). METHODS: A questionnaire was designed to collect data from the pharmaceutical companies submitting reimbursement applications of new medicines or medicines with new therapeutic indications (NMNTI) to the PMH between January 2007 and June 2011. A total of 119 NMNTI were analyzed using the Turnbull non-parametric estimator and Accelerated Failure Time regression models with Gaussian mixture distributions allowing for interval, left and right censoring. Model selection was conducted by backward stepwise elimination based on Akaike’s Information Criterion. RESULTS: Median time from application to PMH decision was 292 days (95%CI: 270-336) in ambulatory and 481 days (95%CI: 398-819) in hospital medicines. Evidence was found that these decision times were significantly (p<0.001) increased when the therapeutic value assessment was based on expert panels (63%), multiple comparators (22%) and Oxford CEBM level of evidence less than 1A (19%); and economic value assessment was relative to cardiovascular (58%) or immunomodulatory non-oncology medicines (44%) and included an economic evaluation study proactively provided by pharmaceutical companies (37%) or enforced by the PMH (103%). CONCLUSIONS: Adequate survival analysis is useful to understand accessibility to new medicines or medicines with new therapeutic indications. Furthermore, substantial problems were found in the accessibility to these medicines in Portugal since 2007.