2016 Volume 6 Issue 3 Pages 345-353
It has been 2 years since Japan also established a system for preparing, submitting, and publishing a risk management plan (RMP) when applying for drug approval. If an RMP functions as it should, even a hypothetical substance that is “very effective, but with a very high risk of adverse reactions” should theoretically have a greater chance of becoming a drug that helps patients to fight disease. In other words, the risk minimization plan in the RMP could successfully minimize the occurrence of serious adverse reactions, while implementation of a risk monitoring plan could aid the timely and accurate detection of new findings unknown at approval. These findings would be included in the risk minimization plan, enhancing it further. However, because it has only been to 2-3 years since RMPs were introduced in Japan, there is still a long way to go before this kind of ideal scenario is realized. Introduction of a pharmacoepidemiologic perspective may be an important factor in making improvements. A sincere effort toward learning this approach will enable the industry to make even more contributions to healthcare and patient’s lives.
