Track record of clinical development and regulatory review of new drugs in Japan Approved items 2000-2011
Shingo Hasefuji (Chief Scientist, The Office of Pharmaceutical Industry Research )
Shunsuke Ono (Associate Professor, Department of Drug Evaluation Science, Graduate School of Pharmaceutical Sciences, The University of Tokyo)
(No. 55: Published November 2012)
In 2011, 131 new drugs were approved, the largest number of new drugs approved since the survey was conducted. In addition, since FY2011 was the final year of the "Five-Year Strategy for the Creation of Innovative Drugs and Medical Devices," the target (median) review period for FY2011 was 12.0 months for regular review items (9.0 months for the administration and 3.0 months for the applicant) and 9.0 months for priority review items (6.0 months for the administration and 3.0 months for the applicant), which was set initially. In 2011, various efforts were made to achieve a median clinical development time of 42 months.
The median clinical development period in 2011 was 42.2 months (3.5 years) and the median review period was 10.1 months (0.8 years), which was 6.3 months longer than in 2010 but shorter than in other years. The review period was 4.7 months shorter than in 2010, the shortest since the 2000 survey.
Although the review period has been shortened, it will be necessary to promote the systems already in place to combat drug lag, such as expediting the review process through the advance evaluation consultation system, adhering to the standard timeline of the review process, making the review process more transparent through the project management system, and clarifying the review process through the establishment of guidelines. It will be necessary to promote the systems already in place to combat drug lag. In addition, it will become increasingly important to strengthen the collaboration between the examination division and other divisions within PMDA and to enhance organizational capabilities in order to promote examinations in the future, such as by enhancing training programs for the increased number of examiners, collaborating with the safety division to take safety measures, and collaborating with the medical device examination division in the examination of new drugs with companion diagnostic reagents. This will become more and more important in the future.
In order to deliver more effective and safer drugs to the medical community faster, it is expected that the government and applicants will cooperate and continue to discuss mutual operational efficiency and a higher quality review system.
One hundred thirty one of new drugs were approved in 2011, which was the most since the survey has been started. According to this strategy, the Pharmaceuticals and Medical Devices Agency (PMDA) has been promoting "Life Innovation" through creation of innovative drugs and medical devices originated in Japan. According to this strategy, Pharmaceuticals and Medical Devices Agency (PMDA) has set the goal of approval time in 2011 for standard review in 12 months, for priority review in 9 months. Many actions have been implemented to achieve this goal.
However, the median clinical development time was longer than 2010 by 3.5 years and 10.1 months (0.8 years) respectively. clinical development time was longer than 2010 by 6.3 months, review time was the shortest between 2000 and 2010, and was shortened by 4.7 months, compared Although the median clinical development time was longer than 2010 by 6.3 months, review time was the shortest between 2000 and 2010, and was shortened by 4.7 months, compared with 2010.
Reliable execution of actions such as introduction of Prior Assessment Consultation, introduction of standardized timelines and strengthened Further improvement of training for inexperienced reviewers Further improvement of training for inexperienced reviewers should be considered and further cooperation between the Office of New Drugs/Biologics and the Office of Safety to Further improvement of training for inexperienced reviewers should be considered and 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. In the future, discussions on a regulatory framework will be held in the Office of Safety and the Office of New Drugs/Biologics.
In the future, discussions on a regulatory approval system considering the quality and efficiency of the regulatory review between regulatory In the future, discussions on a regulatory approval system considering the quality and efficiency of the regulatory review between regulatory authority and sponsor are also essential so we can provide useful drug for the patients in a timely manner.