Clinical Development and Review Times of New Drugs in Japan
Taro Ishibashi (Research Fellow, Office of Pharmaceutical Industry Research)
Shunsuke Ono (Associate Professor, Graduate School of Pharmaceutical Sciences, The University of Tokyo)
No.47 : October 2009
Changes in clinical development time (initial clinical trial plan notification (CTPN) to NDA), review time (NDA to approval), and development time ( Clinical development times were fluctuating.
Clinical development times were fluctuating, with a median of 59.5 months (5.0 years) during 2000 ・2008 and 44.6 months (3.7 years) in 2008. Use of foreign clinical data in Japanese NDAs was increasing and contributing to abridge clinical development times. Review times were on a decline since the establishment of PMDA in April 2004, with a median of 20.6 months (1.7 years) and 44.6 months (3.7 years) in 2008. No improvement, however, was observed in the time spent from the No improvement, however, was observed in the time spent from the submission of responses to the first set of queries after the Interview Meeting and subsequent queries to the Expert Meeting, which accounted for two- thirds of the review time. The applicants and evaluation of PMDA
Multiple regression analyses to estimate factors associated with the length of the three time periods suggested that clinical development times were Results also indicated that review times were significantly shorter in NDAs submitted to the Expert Meeting, which accounted for two thirds of the review time. Results also indicated that review times were significantly shorter in NDAs submitted to PMDA after April 2004 and drugs designated as priority reviews. Results also indicated that review times were significantly shorter in NDAs submitted to PMDA after April 2004 and drugs designated as priority reviews.
Nevertheless, measures such as standardized review timelines with clear milestones, efficient query-and-response procedures, and the use of a more efficient query-and-response procedure are necessary to ensure that PMDA's recent performance is in line with the standardized review timelines. Nevertheless, measures such as standardized review timelines with clear milestones, efficient query-and-response procedures, and re-examination of the role of the Pharmaceutical Affairs and Food Sanitation Council should be The PMDA has been working with the PMDA to further shorten the process time of both the Pharmaceutical Affairs and Food Sanitation Councils, and to improve the quality of the PMDA's services. The role of the Pharmaceutical Affairs and Food Sanitation Council should be considered, in addition to the ongoing increase in PMDA staff, implication of pre-NDA evaluation consultations, and strict time management, to further shorten the process time of both the regulatory agencies and applicants and achieve the target review time set for fiscal year 2011 in light of the 5-Year Strategy for the Creation of Innovative Pharmaceuticals and Medical Devices.