Track record of clinical development and regulatory review of new drugs in Japan Items Approved 2000-2009
Taro Ishibashi (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. 50: Published in September 2010)
The study analyzed the clinical development period, the review period, and the development period for the two combined, as well as factors related to their length, for new drugs approved in Japan from 2000 to 2009.
The median clinical development period in 2009 was 48.2 months (4.0 years) and the review period was 19.1 months (1.6 years). The relationship between clinical development time, review time, and length of development time and factors related to the approved product, applicant company, clinical development, and approval review was analyzed. The clinical development period was significantly shorter for items other than NMEs. In addition, the review period was significantly shorter for items for which applications were submitted after the establishment of PMDA and priority review items. While the review period was significantly shorter for items for which pre-application consultation was conducted, the clinical development period was significantly longer.
Although the review period has been shortening in recent years, in order to achieve the FY2011 target set in response to the "Five-Year Strategy for the Creation of Innovative Drugs and Medical Devices," the time required for both the administration and the applicant to reduce the time required for review must include not only the ongoing increase in PMDA staff, the introduction of a pre-evaluation consultation system and strengthening of review progress management, but also In addition to increasing the number of PMDA staff, introducing a pre-evaluation consultation system, and strengthening the progress management of the review process, it is necessary to consider setting a standard timeline for the process, improving the inquiry items, and reviewing the Pharmaceutical Affairs and Food Sanitation Council. In addition, it is expected that discussions will be held on an approval review system that not only shortens the length of time, but also takes into consideration the efficiency and burden of work for both the administration and the applicant, and the quality of the review process.
Changes and factors associated with the length of clinical development, regulatory review, and the overall development time of new drugs approved in The median clinical development time and review time and the overall development time of new drugs approved in Japan during 2000-2009 were analyzed.
The median clinical development time and review time in 2009 were 48.2 months (4.0 years) and 19.1 months (1.6 years), respectively. suggested that clinical development times were significantly shorter for non-NMEs, drugs designated as priority reviews, drugs with conditional The review times were significantly shorter for NDAs submitted to PMDA after April 2004 and for priority reviews. The effects of pre-NDA consultations were ambivalent; the review time was significantly shorter, but clinical development was The effects of pre-NDA consultations were ambivalent; the review time was significantly shorter, but clinical development was prolonged.
Review times are becoming shorter, but measures such as introduction of standardized timelines for the review process, improvement in the query-and-response procedures, and re-examination of Review times are becoming shorter, but measures such as introduction of standardized timelines for the review process, improvement in the query-and- response procedures, and re-examination of the role of the Pharmaceutical Affairs and Food Sanitation Council should be considered, in addition to the ongoing increase in PMDA staff, impl The PMDA is a non-profit organization that provides assistance to the regulatory agency and applicants in the review process, and is responsible for the review process. The PMDA should be considered in addition to the ongoing increase in PMDA staff, implication of prior assessment consultations, and strict time management, to shorten the process time of both the regulatory agency and applicants and achieve the target review time set for fiscal year 2011 based on the 5-Year Strategy for the Creation of Innovative Discussions on a regulatory approval system considering the efficiency and burden of both the regulatory agency and the applicant, as well as the Creation of Innovative Pharmaceuticals and Medical Devices. Discussions on a regulatory approval system considering the efficiency and burden of both the regulatory agency and the applicant, as well as the quality of the regulatory review, rather than just the duration, are essential.