Pharmacovigilance Services in Japan

In Japan, the Pharmaceutical and Medical Device Agency (PMDA) which works alongside the Ministry of Health and Labour welfare (MHLW) oversees post-marketing surveillance of medicinal products and medical devices, and takes appropriate safety measures with the help of their unique three-pillar safety system which covers safety review of the medicinal product, post-marketing safety measures, and relief services for adverse health effects. Reporting of adverse events in Japan is voluntary and can be reported by healthcare professionals via email, fax, and post, the general public can report through the website, and marketing authorizing holders (MAH) can report via electronic transmission, post, or over the counter. All this safety information including adverse drug reactions and infections caused by medicines or medical devices is collected and stored in the adverse drug reaction database (ADR-DB). Further, the scientific analysis of this data is conducted to investigate the causal relationship and the report of this investigation is then submitted to the MHLW to take further actions to safeguard the use of pharmaceuticals and medical devices. Recently, Japan has been implementing new techniques such as data mining methods and sentinel institution networks for accurate and quick responses to the problems to prevent as well as predict safety concerns. Furthermore, information on the proper usage of medicines and medical devices is available on the website for patient use.

AAs a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Japan that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.