Abstract
Based on Japan-GCP (Good Clinical Practice), study sponsors disseminate safety information for subject protection to principal investigators and medical institution heads (PIs). The Japan Pharmaceutical Manufacturers Association (JPMA) published the guidance of safety communication with PIs in 2009. More than 10 years passed since this proposal, during which time the environment surrounding clinical trials in Japan have changed, such as an increase in multi-regional clinical trials. In 2019 to 2020, the surveys on communication of safety information in clinical trials were carried out to medical institutions and study sponsors (companies) by JPMA. The results showed the urgent and significant safety information were disseminated more rapidly than other non-urgent or non-significant. It was also confirmed that the JPMA-recommended listing format was commonly used to disseminate safety information. On the other hand, the amount of safety information communicated to PIs has significantly increased in the last decade, with a considerable proportion of foreign post-marketing information caused by Japanese specific requirements. This had been the issue that could not be solved due to the regulation. A partial revision to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices was enacted in 2019. The new regulation allows to exempt a part of foreign post-marketing cases from reporting to the regulatory authority and dissemination to PIs. Meanwhile, under the new regulation, sponsors are obliged to disseminate safety information not only the investigational product, but also other product defined in the protocol such as concomitant products (called as “products used in the study”) to the PIs. As the result, the amount of safety information to be disseminated is expected to increase further, so well-balanced dissemination method is required. In response to the changes caused by the new regulations, it is important that sponsors deal with new issues on dissemination of safety information for ensuring subject protection in clinical trials.
