Drug Evaluation Committee Points to keep in mind regarding post-marketing clinical trials other than post-marketing clinical trials for reexamination and reevaluation" Information Session held on October 27, 2022
Nov 07, 2022
The Ministerial Ordinance for Partial Amendment of the Ordinance for Enforcement of the Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals and Medical Devices (hereinafter referred to as "Pharmaceutical Affairs Law") and the Ordinance for Enforcement of the Clinical Research Law was promulgated on September 30, 2022, and came into effect on the same date. This amendment was made in accordance with the "Summary of Considerations on the Review of the Clinical Research Law after Five Years of Its Enforcement" (by the Clinical Research Subcommittee of the Health Sciences Council) published on June 3, 2022, which stated that "Post-marketing clinical trials other than post-marketing clinical trials for re-examination and reevaluation are not subject to the Clinical Research Law and that companies should be "responsible for planning and managing the trials. The revision is based on the following: "In cases where a company is "the person who should be responsible for the planning and operation of the study," a necessary review should be conducted so that the study can be conducted in accordance with appropriate standards separately under the Pharmaceutical Affairs Agency Law.
In order to ensure that the newly defined "post-marketing clinical trials other than post-marketing clinical trials for reexamination and reevaluation" are planned and conducted more appropriately, we have prepared a video and materials to explain the points of revision as well as points to keep in mind when planning and conducting such trials. We hope this will be of help in responding to the revision.