Even though Japan’s new Pharmaceutical Affairs Law (PAL) came into effect on April 1, 2005, the Ministry of Health, Labor and Welfare (MHLW) is still continuing to develop and release new guidance documents. The implementation of the new PAL has revamped the medical device regulatory environment, calling for new procedures to register and market a device in Japan. In particular, a foreign company selling their device in Japan is required to have a Marketing Authorization Holder (MAH). The MAH will act as a regulatory control mechanism, granting final permission for the release of the device into the Japanese market.
A MAH is required to designate up to three people to act as controllers and oversee the manufacturing, distribution and market release of the device. Specifically, the Post-Marketing Safety (PMS) Controller is responsible for Good Vigilance Practice (GVP); this includes post-marketing surveillance, the evaluation of safety information, and the planning and implementing of countermeasures to ensure better safety of the device. The PMS Controller is also responsible for maintaining all PMS documentation, including adverse effect (AE) reports.
All three MAH controllers work collectively to determine how to report AEs to the Pharmaceutical and Medical Device Agency (PMDA). While the PMDA has not yet released detailed guidelines on AE reporting, some general categories and timeframes have been provided. First, death or serious illness resulting from the device should be reported within seven days; second, hospitalization, physical disorders or other very serious effects need to be reported within 14 days; finally, less serious effects should be reported within 30 days. However, the current AE regulation under the new PAL recommends that the MAH contact the PMDA to determine the best course of action, and presently, most AEs are dealt with on a case-by-case basis. Additionally, if an AE occurs in a country outside of Japan, and that country requires AE reporting for the incident, the AE should also be reported to the PMDA.