Abstract
Regulatory affairs committee of Japan Pharmaceutical Manufacturers Association (JPMA) performed questionnaire survey for member company to grasp pharmaceutical development status in Japan, a development strategic tendency and analyzed project number change, trend in projects, ratio of MRCT (the multi regional clinical trial) in each development phase, and pattern of clinical data package for projects in development/submission. As a result, the number of projects under development increased to 805 in 2014, from values in the past three years. In a little less than 40% projects is considered global simultaneous application, and this tendency was markedly seen with projects by MRCT conduct, and the importance of the MRCT strategy for the drug lag elimination was confirmed. In addition, the MRCT conduct ratio with the anticancer drugs was higher than in other therapeutic areas. We also confirmed that the ratio of MRCT increased in later phases in this investigation, but several projects involved global development from early stage, suggesting the development strategy in Japan became diversified. The MRCT strategy is expected to contribute the global simultaneous development in delivering an innovative medicine to the Japanese patients earlier.
