Track record of clinical development and regulatory review of new drugs in Japan Items approved from 2000 to 2013
Koichi Genda (Former Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)
Shunsuke Ono (Associate Professor, Department of Pharmaceutical Evaluation Science, Graduate School of Pharmaceutical Sciences, The University of Tokyo)
(No. 63: Published November 2014)
In 2013, 123 new drugs were approved, following 131 in 2011 The median clinical development time in 2013 was 35.3 months overall, 50.0 months for NMEs, and 29.6 months for non-NMEs Compared to 2012, the overall time was 6.3 months and 5.7 months for NMEs, Compared to 2012, the overall review period was 6.3 months shorter, 5.7 months shorter for the NME, and 4.6 months shorter for the non-NME, making it the shortest in the survey since 2000 for both the overall and NME. On the other hand, the median review period in 2013 was 10.1 months overall, 11.0 months for NME, and 9.8 months for non-NME, 0.6 months overall, 0.9 months for NME, and 0.8 months for NME, but all were less than one month longer than in 2012, suggesting that the review periods were comparable to those in the past. The review periods were comparable to those in the past.
Compared to 2000, the clinical development period and review period have been significantly shortened. In the most recent three-year period from 2011 to 2013, the clinical development and review periods were generally stable. It is expected that the clinical development period will be further shortened not only for Phase II and III, but also for Phase I through active use of overseas data, participation in international and Asian clinical trials, and innovations in clinical data packages.
On the other hand, further shortening of the review period may be possible if the systems already in place, such as expediting the review process through effective use of the pre-evaluation consultation system, adherence to the standard timeline of the review process, and transparency of the review process through the project management system, are promoted without fail. However, it is important to strengthen the collaboration between the examination division and other divisions within the PMDA and to enhance organizational capabilities, such as leveling the workload by accelerating the exchange of inquiries and examination reports, enhancing training programs to accommodate the increased number of examiners, and collaborating with the Safety Division and the Medical Device Examination Division. It is hoped that the PMDA will steadily promote these efforts to ensure a fulfilling examination process.
In addition, the electronic data submission at the time of application for approval required by PMDA aims to promote more rational and efficient evaluation and decision-making processes in review and consultation by PMDA's own analysis and research using clinical data and other data. It is expected that the administration and applicants will continue to cooperate with each other and continue discussions on mutual 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.