Track record of clinical development and regulatory review of new drugs in Japan Approved Items 2000-2014
Kohei Kagayama (Chief Scientist, The Office of Pharmaceutical Industry Research )
Shunsuke Ono (Associate Professor, Department of Pharmaceutical Evaluation Science, Graduate School of Pharmaceutical Sciences, The University of Tokyo)
(No. 68: Published November 2015)
In 2014, 138 new drugs were approved, the highest number of new drugs approved since 2000 The median clinical development time for all drugs approved in 2014 was 36.2 months, 48.2 months for new active ingredient drugs ("NMEs"), and 33.3 months for non-NMEs Compared to 2013, the median clinical development time for all drugs was Compared to 2013, the overall review period was 0.9 months longer, 1.8 months shorter for NMEs, and 3.7 months longer for non-NMEs, making it the shortest for NMEs in the survey since 2000. On the other hand, the median review time in 2014 was 10.1 months overall, 10.5 months for NMEs, and 9.9 months for non-NMEs, and although it was 0.5 months shorter for NMEs and 0.1 month longer for non-NMEs than in 2013, the overall review time was the same and comparable to that in Europe and the US.
Compared to 2000, the clinical development period and review period have been significantly shortened, and the most recent four-year results from 2011 to 2014 indicate that the shortened period is now almost firmly established. It is expected that the clinical development period will be further shortened through active use of overseas clinical data, participation in international joint clinical trials and Asian clinical trials, and innovations in clinical data packages. In addition, further shortening of the review period and streamlining of the review process will 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 steadily promoted. At the same time, there are high expectations for improving the quality of audits in the future. It is important to strengthen cooperation between the examination division and other divisions within the Pharmaceuticals and Medical Devices Agency (hereinafter referred to as "PMDA"), such as leveling up operations by making inquiries and examination reports earlier, enhancing training to accommodate the increased number of examiners, and collaborating with the Quality Control Division and the Reliability Assurance Division, which will result in more fulfilling examinations. We hope that these efforts will result in a more fulfilling examination process. In addition, the PMDA's requirement for electronic data submission at the time of application for approval states that the PMDA itself will conduct analysis and research using clinical data and other data to promote more rational and efficient evaluation and decision-making processes in the review and consultation process. It is expected that the government and applicants will continue to cooperate in discussions on mutual operational efficiency and a higher quality review system, so that more effective and safer drugs can be delivered to the medical community more quickly.