OBJECTIVES:  Following marketing authorization by the Italian Medicines Agency (AIFA), drugs need an approval step at regional level before being available to patients. The main purpose of this research is to define time to market (TTM) for innovative drugs, from the AIFA Pricing and Reimbursement (P&R) assessment, to regional patient access. METHODS:  A selection of new molecular entities (NMEs), which received a P&R assessment by AIFA in the 2012-2016 period, was considered. The sample included 39 drugs with different characteristics: innovative (n=17), non-innovative (n=22) and belonging to different therapeutic areas (i.e. antivirals, oncologic, cardiometabolic, and Central Nervous System). A desk research on the Italian Official Journals (Gazzette Ufficiali) was carried out to collect P&R approval dates. The dates of first regional dispensation were obtained through the IMS Health Hospital database, which gathers data on hospital and local healthcare unit direct distribution. RESULTS:  The TTM is more rapid for innovative drugs compared to the non-innovative ones. The national average for TTM is 2.8 months; 3.7 and 1.8 for non-innovative and innovative drugs respectively. Regions show a high variability in the mean time (months) required for patients access. The regional analysis on innovative drugs shows a north-south gradient. The Northern regions (i.e. Lombardy, Piedmont-Valle d’Aosta, Tuscany) have shorter TTM (1-1.3 months). On the contrary, the southern regions (i.e. Sicily, Calabria, Basilicata, Molise) show longer TTM (>2.1 months). TTM is shorter for antivirals (1.4 months) compared to oncologics (2.4 months). CONCLUSIONS: The regional access is an important additional step that new molecules have to go through, towards final patient access. This process appears to be particularly time consuming especially in some regions. Regional measures and clear access pathway for drug formulary inclusion, while having a fundamental assessment role, should also be particularly devoted to guarantee a fast patient access especially for innovative molecules.