27th Annual EuroMeeting

In spring 2014, the Pharmaceuticals and Medical Devices Agency (PMDA) developed the Third Mid-term Plan based on the results of the Second Mid-term Plan, in which we achieved the shortened the review time of new drug approval, established a risk management plan, shortening the review period of relief service, and established the structures for the promotion of regulatory sciences. In the new plan, we will accelerate drug development, especially for innovative ones, by improving the scientific quality of review, consultation, and post- marketing safety measure through the regulatory sciences such as the science board, advanced review/consultation system, and other approaches. This session contains the report for recent and future challenges of PMDA, followed by Q&A with the audience to offer the opportunity to interact directly with PMDA senior level representatives regarding almost all services rendered by PMDA, including international programmes