A Japanese concept of considerations for evaluation of dental materials for tooth bleaching.

Recent advances in bleaching technology, such as bleaching ingredients, have accelerated the development of tooth whitening materials to change the color of natural teeth toward a lighter or whiter shade. Some bleaching materials are used for patients in combination with auxiliary medical devices to activate the bleaching materials by a light or heat source. Bleaching ingredients can be a poisonous and deleterious substance. Some bleaching materials are used in dental offices and the others at home. In clinical development of bleaching materials, appropriate evaluation of safety and efficacy is required according to the intended use. For appropriate and swift approval of the emerging bleaching materials, guideline on evaluation of dental whitening materials was discussed in a commissioned project by the Ministry of Health, Labour and Welfare of Japan for FY2021. Here, we summarize the current principles of the premarketing evaluation of the safety and efficacy.

Rapid Globalization of Medical Device Clinical Development Programs in Japan　- The Case of Drug-Eluting Stents.

Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012. The reduction accompanied a shift in clinical development from a succession pattern (initial product development and approval overseas followed by eventual entrance into the Japanese market) to parallel development (employing multiregional clinical trials (MRCTs)). Although resource-intensive in the short-term, MRCTs are proving to be an effective tool in simultaneous global product development. Creative study designs and the absence of significant ethnic differences in Japanese subjects regarding DES safety and efficacy and the pharmacokinetic behavior of their coating drugs propel this process. More general factors such as medical need and industry incentivization also encourage this shift. Physicians' preference for DES over other percutaneous coronary interventions, the expanding global DES market, and streamlined development and approval prospects each motivate industry to continue investing in DES product development. The efforts of various stakeholders were also integral to overcoming practical obstacles, and contributions by 'Harmonization by Doing' and a premarket collaboration initiative between the USA and Japan were particularly effective. Today, USA/Japan regulatory cooperation is routine, and Japan is now integrated into global medical device development. MRCTs including Japanese subjects, sites, and investigators are now commonplace.