Track record of clinical development and regulatory review of new drugs in Japan Approved items 2000-2012
Shingo Hasefuji (Former Chief Scientist, The Office of Pharmaceutical Industry Research )
Shunsuke Ono (Associate Professor, Department of Drug Evaluation Science, Graduate School of Pharmaceutical Sciences, The University of Tokyo)
(No. 62: Published in January 2014)
In 2012, 120 new drugs were approved, following 131 in 2011 The median clinical development time and review time in 2012 were 41.6 months and 9.5 months, respectively, which were 0.6 months shorter in both clinical development and review time compared to 2011, and the review time was the shortest since the 2000 The median review period was 9.5 months, 0.6 months shorter than in 2011, and the review period was the shortest since the 2000 survey.
The clinical development period and review period have been significantly shortened since 2011. It will be necessary to continue to shorten the clinical development period through active use of overseas data and participation in international clinical trials, and to promote the systems already in place, such as speeding up the review process by effectively utilizing the pre-evaluation consultation system, adhering to the standard timeline of the review process, and making the review process more transparent through the project management system. It will be necessary to promote the systems that have already been introduced.
In addition, the PMDA should strengthen collaboration between the examination division and other divisions within the PMDA, such as leveling the workload by moving up the exchange of inquiries and examination reports, enhancing training programs to accommodate the increased number of examination personnel, and collaborating with the safety division to take safety measures and with the medical device examination division for new drug examinations involving companion diagnostic products, Strengthening organizational capabilities will become increasingly important to effectively promote examinations in the future.
The establishment of a U.S.-style review system in which electronic data is submitted at the time of application and analyzed and evaluated by the PMDA itself is expected to reduce the number of inquiries. On the other hand, there are concerns about the impact on the examination period, which has already been shortened.
As new initiatives are introduced, it is expected that the government and applicants will cooperate with each other to continue discussions on operational efficiency and an even higher quality review system so that more effective and safer drugs can be delivered to the medical community more quickly.