In recent years, because the dry skin problem has become very common, it is getting the more important to preserve the barrier function of the skin. Although protecting the skin against water loss is one of the representative factors of its barrier capabilities, there is no report until now about the relationship between daily use of bath liquid and the moisture-keeping capacity of the skin.   In this study we examined how the skin condition can be improved after 14 straight days of employment of our bath liquid ‘Ulmore®’including Polyquaternium-10 and several moisturizing ingredients. Polyquaternium-10 is a Cationized Cellulose and is widely formulated in shampoos and hair conditioners.   We found that the application of Ulmore® for 10 or 14 days significantly maintained sratum corneum water content (SCWC) and transepidermal water loss (TEWL) compared with the placebo application. This result suggests that this is because our bath liquid covered the stratum corneum and protected the skin from water loss caused by the environmental factors like low humidity.   Thus we conclude that daily use of the bath liquid has a beneficial effect on skin moisture.

Monitoring of the safety profile for the approved medical products consists of routine pharmacovigilance activities for all drugs and additional pharmacovigilance activities for product-specific concerns. Signal management is an important part of routine pharmacovigilance activities, so EMA and FDA have published the guidelines for signal management in various documents. The AMED Risk Management Plan （RMP） research group, which started its activities in 2018 to enhance risk management plan in Japan, reviewed the guidelines and related articles and then put together the principles of signal management. The guidelines in EU and US describes the signal detection and evaluation methods including points to consider when conducting them, responsibilities of each action, and the procedures that the regulatory authorities disclose the outcome of their activities, in addition to the principles and procedures of signal management. Through the guidelines, they establish transparency for public including pharmaceutical industry. Our group first created the Japanese definitions of signal-related terms. Based on them, we created high-level concept for a series of activities from signal detection to risk identification and discussed the future vision of signal management in Japan.