OBJECTIVE. The Balduzzi law (189/2012) introduced several changes aimed at promoting the country's development through a higher level of health protection and at bridging the gap left by the rationing of healthcare resource from the Spending Review (135/2012). Reducing the time to drug market access is one of the main purposes. The aim of the research is a critical analysis of this law to understand its actual and future impact on the healthcare scenario. METHODS: . An evaluation of the laws issued in the last three years that aimed at regulating the drug market was carried out. To build a future scenario analysis, we focused our attention on the Balduzzi law and two of its articles (11 and 12) and on the new drugs approved by AIFA and commercialized under the new regulation.  RESULTS: . The changes that will have a major impact on the drug market are: the allocation of the medicines approved under centralized procedure in the non-negotiated C Class within 60 days from the publication in the Official Gazzette of the European Union and the direct placement of generics and biosimilars in the reimbursement class of the originator without any price negotiation.  As of now, a total number of 49 drugs have been included in the non-negotiated C Class, within this new group there are 15 first drug authorizations. CONCLUSION: The new reform can be potentially an interesting innovation to speed up market access, though the impact of including new drugs in the C class (at patient charge) before the price negotiation is still under debate. The increased competitiveness coming from having a faster introduction in the market of generics/biosimilars could lead to important savings for the National Healthcare System over the next years.