Development Duration of New Drugs in Japan Clinical Development Period and Approval Review Period
Kuniaki Yasuda (Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)
Shunsuke Ono (Associate Professor, Department of Drug Evaluation Science, Graduate School of Pharmaceutical Sciences, The University of Tokyo)
(No.42: Published in September 2008)
The "clinical development period" from the date of notification of clinical trial to the date of application for approval for new drugs in Japan, the "approval review period" from the date of application for approval to the date of approval, and the "development period" which is the sum of these periods, were clarified, including annual changes and the relationship between drug characteristics and development period, characteristics which are shown quantitatively based on data on approved drugs. The data are used to identify the characteristics of the approved drugs.
The domestic development period for drugs containing new active ingredients that were subject to normal review has not changed over the past 10 years, but rather has become longer. However, for priority review items for which measures were taken to expedite development and review, i.e., drugs with special criteria/requirements for approval/rejection such as few clinical trial results in Japanese patients, the period was shortened. In order to make Japan an attractive place for new drug development, it is desirable to implement measures to shorten the development period for new drugs as a whole. In addition, it would be desirable to see progress in the discussion of what level of clinical trial results and development time is appropriate for the regulatory authorities, new drug development companies, and patients, in terms of the minimum time required to collect acceptable clinical results for a drug.
The total review period for new drugs approved in 2007 was 20.0 months. Compared to 2006, the total review period for new drugs was 2.1 months, 6.1 months for regular review items, and 1.5 months for priority review items. The total review period, which had been lengthened in 2005 and 2006 after the establishment of the Comprehensive Agency for Drug Evaluation and Research (CDER), was reduced for the first time in 2007. The review period for items approved in the U.S. (CDER) in 2007 was 10.0 months, while that in Europe (EMEA) was 13.5 months. The difference in review times between Japan and the U.S. is 10.0 months, and the difference between Japan and Europe is 6.5 months. Although there are signs that Japan is shortening its approval review period, the gap between Japan and the U.S. and Europe is still large.
In order for companies to start new drug development in Japan as early as possible, Japan needs to be regarded as an attractive drug market and an attractive place for drug development for companies. In order to realize the goal of increasing the benefits of pharmaceuticals to the public through faster domestic development of new drugs, progress in evidence-based discussions among the public, policy makers, and the pharmaceutical industry on development time, factors influencing companies' development strategies, and the effects of administrative measures is strongly encouraged.