Changes in the environment surrounding a phase 1 trial in Japan
Journal Title: Journal of Analytical Bio-Science - Year 2012, Vol 35, Issue 5
Abstract
A new Good Clinical Practice (GCP) ministerial ordinance was established in 1997 based on the GCP prepared by ICH (International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (abbreviated as ICH -GCP) for the clinical trials of pharmaceutical products, and has improved the ethical and scientific levels of clinical trials in Japan. However, the number of clinical trials has decreased continuously due to various problems including the long implementation time and quality of trials, or the high costs of the trials. Therefore, in 2003 the Minister of Health, Labour and Welfare (MHLW) instituted a "Three-year clinical trial activation plan" in cooperation with the Ministry of Education, Culture, Sports, Science and Technology (MEXT), and launches the environmental consideration of clinical trials. Those measures and policies aimed to develop an environment under which government, academia research groups, and industry can cooperate in the search for seeds. The biomarkers and diagnostic methods for the seeds, and the approaches for personalized medicine have been continued. In 2012, MEXT and MHLW launched a started new clinical trial activation plan. In addition, the MHLW supervised the strategies needed to identify and mitigate passible risks for the first-in-human clinical trials using investigational medical products to support the swift shift too phase 1 trial from a non-clinical study in Japan. In this way, the environment to perform a phase 1 trial and translational research has been changing so that new medicine can be swiftly provided to patients in Japan.
Authors and Affiliations
Shinji Miyoshi
New outlook for technology of medical laboratory test
The background for the technology of a medical laboratory test is very extensive. In this issue, a new outlook for the technology of medical laboratory tests is presented in five feature articles from various viewpoints....
Consideration of reactivity of human, bovine and egg albumins in the dye-binding method and a standard material for determining the human serum albumin
A protein error of three sulfonephthalein pH indicators, bromophenol blue (BPB), bromocresol green (BCG) and bromocresol purple (BCP) by human, bovine and egg albumins (HSA, BSA, EGA) was investigated in order to find a...
Basic examination of an automated coagulation analyzer, Coapresta 2000, and introduction to 24-hour emergency service
Recently, in addition to accuracy and reliability, clinical laboratories have also been under pressure to produce results with speed around the clock, A novel automated coagulation analyzer, Coapresta 2000 (CP2000: Sekis...
Advances of urinary protein and albumin analysis
Cardio-renal association
The cardio-renal association includes the widely known relationship between kidney function and cardiovascular disease (CVD). The interaction between renal and cardiac functions is very important for regulatory functions...