OBJECTIVES: Pricing regulation in Japan is thought to be conservative, however over the last years, an acceleration of pricing regulation changes has occurred. We propose to review the dramatic pricing regulation changes that have occurred especially in 2012. METHODS: Collection and analyses of changes have been performed through literature review of public sources and key opinion leader’s interviews. RESULTS: One of the main changes concerns pediatric indication that will now induce premium price for drugs from 5% to 20%, conditional to substantial efforts from pharmaceutical companies, including studies in Japan and pediatric formulations. Then, usual cost plus calculation, using the last year as reference for production, labor, distribution costs etc., will now use the average of the previous 3 years to minimize inflation. International reference pricing have been reviewed to minimize the cost impact on NHS. As for generics, although they doubled in volume and value over the last 10 years, they progress slowly: in 2011, generic market was 23% in volume and 9.5% in value. To counter this, doctors are now eligible for generic prescription incentive and high co-payment on brand appears to be the way forward to support generic uptake. Prescription form has been reviewed to ease request for generic substitution. Generics are priced between 30% discount down to 46% discount at the maximum. In parallel, enantiomer drugs will now be discounted by 20% over racemates. This will put them close to generic price (30% discount). However, opportunities for re-pricing up products were closed to prevent orphan drugs from expanding indication market size and later revenue. Finally, high drug costs will be excluded from reimbursement through a process based on drug price distribution to secure convergence toward mean price. CONCLUSIONS: Despite apparent peace and resistance to changes, Japan market is also undergoing dramatic changes.