OBJECTIVES: Resolution nº 2/2004 dictates the criteria to establish the entry prices of new medicines in Brazil. According to it, products are divided into: new products and new presentations. This research will focus in new products, which are classified in: Category I - new product (patented molecule) with scientific evidences of benefit when compared to others of same therapeutic indication (greater efficacy; same efficacy with decreased side effects or same efficacy with lower global cost). Category II - new products not classified as I. Price analysis follows a model of price cap, including two constraints: lowest international price (based on a list of nine countries plus where the product is produced) and cost of treatment, based on an elected comparator. Price for Category I is based on the lowest international price only and, for Category II, the cost of treatment with the chosen comparator and international prices, the lowest of them. The goal of this research is to evaluate the application of price regulation since Resolution nº 2/2004 publication and its consequences regarding to decreasing the costs of medicines for the society. METHODS: Data of price analysis (new products) performed by Office of Economic Assessment of New Technologies of Brazilian Health Surveillance Agency (Anvisa), which supports CMED decisions, were evaluated (2004 – 2011). RESULTS: In * years, 209 new molecules (563 presentations) were analyzed. The mean difference found between the price pleaded by laboratories and the price determined after analysis was: Category I 21%; Category II 39%. Only 7% of new products proved to be innovative, while 93% of the new products were classified as II (either not under patent or without proven benefit). CONCLUSIONS:  Resolution n° 2/2004 has led to lower entry prices and, consequently, decreased the cost to the private and public sector, improving the efficiency of health care.