Abstract
The revised Pharmaceutical Affair Law was implemented in July 30, 2003. This law has made it possible for physicians to perform clinical trials of unapproved drugs or approved drugs for new indications and to use these trials for the New Drug Application. This system is referred to as “investigator-initiated registration-directed clinical trials”. “Investigator-initiated registration-directed clinical trials” must comply with the revised GCP. Therefore, physicians face great difficulty in performing such clinical trials, because physician are not familiar with the Pharmaceutical Affair Law and related regulations and majority of the medical institutions are not adequately equipped for the performance of such clinical trials. Potential problems and perspectives related to the investigator-initiated registration-directed clinical trials will be discussed.
