Clipping Board » Medical Affairs and Administration ─ Medical system, pharmaceuticals, and medical community-related reports
【2006/07/19 United Daily News】【Reporter Chen Huihui / Taipei Report】
Health Minister Hou Sheng-mao stated that he respects professional opinions on how clinical trials should be regulated. As long as it is feasible and can ensure safety, all proposals are open for discussion. Hou also denied having personally criticized former Director of the Department of Pharmaceutical Affairs, Wang Hui-po, as a stumbling block to the development of the clinical trial industry.
Liao Ji-zhou, Director of the Department of Pharmaceutical Affairs, mentioned that Taiwan's clinical trial regulations and execution have reached international standards. For instance, the composition of the Institutional Review Board (IRB) requires that, in addition to clinical physicians, one-third of the members should be from religious and social sectors.
Chen Heng-de, Executive Director of the Center for Drug Evaluation, stated that while there are no strict penalties for hospitals whose IRB composition does not comply with regulations, the Department of Medical Affairs will conduct inspections and request improvements. Both Liao Ji-zhou and Chen Heng-de noted that "foreign countries do not require hospitals conducting clinical trials to be certified in advance," but the Health Ministry mandates that clinical trial investigators must undergo Good Clinical Practice (GCP) training.
Chen Heng-de added that the U.S. Food and Drug Administration (FDA) does not review each clinical trial application individually. If the FDA raises no objections within 30 days of submission, pharmaceutical companies can proceed with human trials. He believes that Taiwan's regulations are much stricter. If the Center for Drug Evaluation finds any issues with a hospital's clinical trial application, it will refer the case to the Health Ministry's Drug Review Committee for further discussion. Based on experience, such cases account for about 25% of applications.
"We hope to return to the spirit of self-regulation," Chen Heng-de said. If a hospital's IRB dares to approve high-risk human trials, the hospital must bear the consequences if problems or disputes arise. He also reminded the public not to hastily agree to participate in human trials. Instead, they should carefully listen to the doctor's explanation and read the informed consent form. If there are any doubts, they should not participate, and they should not feel pressured by personal relationships or fear of displeasing the doctor.
Medical Testing Center: Do Not Agree to Human Trials Lightly
Health Minister Hou Sheng-mao stated that he respects professional opinions on how clinical trials should be regulated. As long as it is feasible and can ensure safety, all proposals are open for discussion. Hou also denied having personally criticized former Director of the Department of Pharmaceutical Affairs, Wang Hui-po, as a stumbling block to the development of the clinical trial industry.
Liao Ji-zhou, Director of the Department of Pharmaceutical Affairs, mentioned that Taiwan's clinical trial regulations and execution have reached international standards. For instance, the composition of the Institutional Review Board (IRB) requires that, in addition to clinical physicians, one-third of the members should be from religious and social sectors.
Chen Heng-de, Executive Director of the Center for Drug Evaluation, stated that while there are no strict penalties for hospitals whose IRB composition does not comply with regulations, the Department of Medical Affairs will conduct inspections and request improvements. Both Liao Ji-zhou and Chen Heng-de noted that "foreign countries do not require hospitals conducting clinical trials to be certified in advance," but the Health Ministry mandates that clinical trial investigators must undergo Good Clinical Practice (GCP) training.
Chen Heng-de added that the U.S. Food and Drug Administration (FDA) does not review each clinical trial application individually. If the FDA raises no objections within 30 days of submission, pharmaceutical companies can proceed with human trials. He believes that Taiwan's regulations are much stricter. If the Center for Drug Evaluation finds any issues with a hospital's clinical trial application, it will refer the case to the Health Ministry's Drug Review Committee for further discussion. Based on experience, such cases account for about 25% of applications.
"We hope to return to the spirit of self-regulation," Chen Heng-de said. If a hospital's IRB dares to approve high-risk human trials, the hospital must bear the consequences if problems or disputes arise. He also reminded the public not to hastily agree to participate in human trials. Instead, they should carefully listen to the doctor's explanation and read the informed consent form. If there are any doubts, they should not participate, and they should not feel pressured by personal relationships or fear of displeasing the doctor.