As of April 2005, “Shihango-rinsyoushiken” defined in the GPMSP was renamed “Seizouhanbaigo-rinsyoushiken” in the revised regulations (GPSP). The relevant part of the GCP was also modified at the same time. Strictly speaking, therefore, post-approval clinical trials are not the same as postmarketing clinical trials. This report provides an explanation of post-approval clinical trials and the related regulations. It is generally considered that post-approval clinical trials, which help gather more clinical information, should be actively pursued for the further development of approved drugs in the post-marketing setting. However, the results of the questionnaire show that pharmaceutical companies are not willing to conduct them, mainly due to the high cost. To improve the economic efficiency of post-approval clinical trials, it is necessary to streamline monitoring activities that account for 40% of the cost.

For about 8, 000inhabitants of Nagato-machi and Wada-mura, Nagano prefecture, various mass screenings have been carried out for this 14years. These are gastric mass survey carried out from 1971, primary health screening from 1972, multiphasic health testing and service from 1978, mass screening for breast and thyroid cancer from 1980 and ultrasonographic mass screening for liver, gallbladder and pancreas cancer from 1983.
Among the total of 38, 593examinees, 90patients 92diseases were detected to be operated. Maligant diseases are 9kinds 40patients 42diseases and benign ones are llkinds 50patients.
The largest number of the diseases is 29gastric cancers. Almost of malignant diseases, 36/ 40patients, were detected sincel978 and their prognosis are very good, namely 2patients of gastric cancer, one hepatoma and one breast cancer have died of the malady and one bile duct cancer died of other disease until now.
The route of detection and prognosis of all operated patients, the present condition and the policy of all mass screenings and the necessity of increase of the examinees, especially the old men and women, are discussed.