Track record of clinical development and regulatory review of new drugs in Japan Approved items from 2000 to 2010
Tatsuya Fukushima (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. 51: Published November 2011)
More new drugs were approved in 2010 than in any other year, with more than 100 items approved. The median clinical development time was 35.9 months (3.0 years) and the median review time was 14.8 months (1.2 years), which were 12.3 months and 4.3 months shorter, respectively, than those in 2009, This was the shortest period between 2000 and 2010.
In recent years, along with the internationalization of clinical trials, the number of items for which data from international clinical trials have been submitted as evaluation data has been increasing, which is expected to further improve the efficiency of clinical development. In addition, the review period has been shortening since 2005, and is expected to continue to do so due to the increase in the number of items for which applications are publicly known, coupled with the scheme of the Review Committee for Unapproved Drugs and Off-label Drugs. However, it is necessary to further improve the review system and review process so that the target review period can be achieved continuously, even if only for items applied for through the normal review process, and many opinions and requests for improvement were received from companies responding to the survey.
In addition, in order to take safety measures for new drugs at an early stage together with pharmaceutical companies, the following issues need to be addressed: collaboration between the review and safety departments; collaboration with the medical device review department in the review of new drugs involving companion diagnostics, which is expected to become increasingly important in the future; and strengthening international collaboration and information sharing, especially with the FDA and EMA, as international joint trials and simultaneous applications with overseas companies are increasing. There are many opinions and requests for strengthening international collaboration and information sharing, mainly with the FDA and EMA, and it will be necessary to consider how to respond to these requests.
Over one hundred of new drugs were approved in 2010, which was more than usual. The median clinical development time and review time in 2010 were 35.9 months (3.0 years) and 14.8 months (1.2 years) respectively which were the shortest between 2000 and 2010, and the former was shortened by 12.3 months and the latter by 4.3 months, compared to the former by 4.3 months. In recent years, the number of N
In recent years, the number of NDAs utilizing data of multinational clinical trials is increasing according to globalization of clinical trials, and it Since 2005, review times have been becoming shorter, and would shorten continuously along with the scheme of "Non-A-Advanced Clinical Trials". Since 2005, review times have been becoming shorter, and would shorten continuously along with the scheme of "Non-Approved and Off-Label Drugs Review Meeting", because of increasing the number of NDAs based on common knowledge and facts on off-label use or off-label drug use. and facts on off-label use or much use experiences abroad in some diseases without conducting clinical trials overall or partially in Japan, that is " Kouchi Application". But further improving the review processes and systems should be considered to meet annual target of review time continuously in the future even without " Kouchi Application", and there is " Kouchi Application". Kouchi Application", and there are many comments and requests for the improvement from respondents of the survey, as described in the tenth chapter.
In addition, there are opinions on review system from the respondents such as further cooperation between the Office of New Drugs/Biologics and the In addition, there are opinions on review system from the respondents such as further cooperation between the Office of New Drugs/Biologics and the Office of Safety to tighten safety measures for new drugs earlier with applicants, as well as between the Office of New Drugs/Biologics and the Office of Medical Devices when new drugs accompanied with companion diagnostics, which would become more important, are reviewed, international cooperation with other regulatory agencies such as the FDA In the case of the Office of New Drugs/Biologics and the Office of Medical Devices as well as between the Office of New Drugs/Biologics and the Office of Medical Devices when new drugs accompanied with companion diagnostics, which would become more important, are reviewed, international cooperation with other regulatory agencies such as the FDA and the EMA as the numbers of multinational clinical trials and simultaneous NDA submissions have been In the future, discussions on a regulatory approval system considering the quality of the regulatory review based on these In the future, discussions on a regulatory approval system considering the quality of the regulatory review based on these comments and requests are also essential.