Track record of clinical development and regulatory review of new drugs in Japan Approved Items 2000-2015
Kohei Kagayama and Shohei Shirakami ( The Office of Pharmaceutical Industry Research Principal Investigators)
Shunsuke Ono, Associate Professor, Department of Drug Evaluation Science, Graduate School of Pharmaceutical Sciences, The University of Tokyo
(No. 69: Published November 2016)
There were 106 new drugs approved in 2015, of which 51 were new active pharmaceutical entities (NPAs), followed by 38 new active pharmaceutical entities (NMEs) and 9 new dosage forms.
The overall median clinical development time for 2015-approved products was 41.5 months, of which 54.0 months were for NMEs and 32.2 months for non-NMEs. In terms of the use of foreign clinical data in domestic regulatory applications, more than half of the NMEs used foreign clinical data as evaluation data, resulting in significantly shorter clinical development times for those items for which foreign clinical data were used as evaluation data. In addition, the number of items for which international clinical trials were conducted in 2015 was 21, the second highest number since 2014 (33 items), indicating that the number of items for which simultaneous global application and approval have been sought has been increasing in recent years.
The median review period for items approved in 2015 was 9.9 months overall, 10.9 months for regular review items, 8.0 months for priority review items, and 5.5 months for expedited processing items. The results of the estimation of factors related to the length of the review period for items approved between 2005 and 2015 after the establishment of PMDA showed that three factors were associated with shorter review periods: being a non-NME item, being a priority review item, and having experience in development in the relevant therapeutic area. The results showed that the following three factors are associated with shorter review times. In addition, a trend toward shorter review times was observed for items approved in 2009 and later, compared to 2005. The performance evaluation of PMDA's approval review by applicant companies has been increasing year by year, and was as high as 80% (median) in the 2015 survey for each approved product. The survey showed that the situation is improving not only in terms of shorter review times, but also in terms of the quality of the review process.
The survey also revealed that there are many issues that need to be improved in the approval review system and process, as well as concerns about the new system, etc. The review process will change significantly with the start of electronic data submission of approval application documents in October 2016. It is expected that the government and applicants will cooperate and continue to discuss each other's work efficiency and a further high-quality review system so that more effective and safer drugs can be delivered to the medical field more quickly.