Great attention should be paid to post-marketing c
For carrying out the related regulations including "Specifications of management of clinical medical agents" set up by the State Drug Administration (SDA), and to aim directly at the existing problems in post-market clinical studies, as well as to strengthen the clinical studies of drugs and to get into the network of international standard, a seminar "Facing the development and challenge of clinical medicine" was held by the Chinese Association of Physicians (CAP) recently.
Dr. Yin Dakui, chairman of CAP at first pointed out that at present remarkable progress in China had been obtained in the multi-center studies of large samples of the new drugs prior to marketing. However, the clinical research and supervision following the marketing of new drugs appeared to be insufficient. With the steadily grown sense of self medical care of patients and the gradual increase of the channels to procure medical agents, the clinical administration and supervision became more and more eminent soon after the marketing of a new medical agent. Some of the pharmaceutical enterprises noted this point, and often proceeded with the pattern of giving free sample drugs to the hospitals for t clinical studies; such practice is considered to be very undesirable. Dr. He Ruyi，an officer of US FDA， said that the focal point of the four stages of clinical research was the safety of drugs. Notwithstanding the animal experimental studies and the clinical tests of three stages carried out prior to marketing of a new drug, the number of clinical cases were too small and the period of testing was not long enough, and some of the complications and the interaction between the medical agents might not be manifested. Consequently, the fourth stage of clinical study using large samples of observation to verify the effectiveness and to evaluate the reliability of a new medical agent was mandatory. The American physicians are required by the FDA to report the severe, unexpected ill effects of a drug within 15 days to the FDA, in the form of voluntary information which to some extent exhibited an action of monitoring the safety of the pharmaceutical products., http://www.100md.com
Dr. Yin Dakui, chairman of CAP at first pointed out that at present remarkable progress in China had been obtained in the multi-center studies of large samples of the new drugs prior to marketing. However, the clinical research and supervision following the marketing of new drugs appeared to be insufficient. With the steadily grown sense of self medical care of patients and the gradual increase of the channels to procure medical agents, the clinical administration and supervision became more and more eminent soon after the marketing of a new medical agent. Some of the pharmaceutical enterprises noted this point, and often proceeded with the pattern of giving free sample drugs to the hospitals for t clinical studies; such practice is considered to be very undesirable. Dr. He Ruyi，an officer of US FDA， said that the focal point of the four stages of clinical research was the safety of drugs. Notwithstanding the animal experimental studies and the clinical tests of three stages carried out prior to marketing of a new drug, the number of clinical cases were too small and the period of testing was not long enough, and some of the complications and the interaction between the medical agents might not be manifested. Consequently, the fourth stage of clinical study using large samples of observation to verify the effectiveness and to evaluate the reliability of a new medical agent was mandatory. The American physicians are required by the FDA to report the severe, unexpected ill effects of a drug within 15 days to the FDA, in the form of voluntary information which to some extent exhibited an action of monitoring the safety of the pharmaceutical products., http://www.100md.com