With the increasing use of overseas clinical data in clinical data packages for new drug application (NDA) in Japan, the relative amount of Japanese clinical data submitted for NDA has been decreasing. Clinical data on Japanese subjects is important for physicians to decide the course of treatment in clinical practice, and the importance of post-marketing surveillance (PMS) as a means of obtaining clinical data from Japanese subjects promptly after the launch is increasing. With the purpose to investigate measures to better utilize PMS, we examined the status of recent PMS in Japan based on review reports of new drugs as well as protocols and relevant documents of PMS conducted at Kitasato Institute Hospital.
Fifty-four of 155 new drugs had conditions for approval, which required sponsors to conduct all-case surveys for a certain period of time after launching. Along with orphan drugs, some drugs used in large patient populations were required to conduct all-case surveys. As for drugs without conditions for approval, many of their protocols stipulated collection of data of over 3000 Japanese patients. Also, some protocols required collection of additional data not necessarily essential for safety evaluation of the drugs. In order to obtain Japanese clinical data in a more precise and timely manner during PMS in Japan, we encourage sponsors and regulatory authorities to consider various specific survey designs based on the characteristics of the drug and to design less burdensome report forms for proper safety evaluation. (Jpn J Clin Pharmacol Ther 2012 ;43(5) :345-351)