Japanese Bridging Studies
As the worldís second largest market, Japan is an attractive and important consideration when planning your global development strategy. Yet the path to registration has unique regulatory hurdles, and must be approached with appreciation and sensitivity for Japanís cultural and ethnic concerns.
Drug development within and for Japan has changed markedly since implementation of the ICH Guidelines in 1998. In particular, Section E5 outlines general guidance for use of foreign data, which led to ìbridging studiesî comparing the pharmacokinetics, safety and tolerability of compounds in Japanese individuals versus Caucasians or other reference populations. Such studies allowed a shorter and focused development program in Japan to confirm safety and efficacy.
Although these guidelines have facilitated approval of numerous compounds, a 2 to 3 year lag still typically exists between a compound's registration in Japan in comparison to its first approval elsewhere. Beyond the "bridging" strategies of the past 10 years, there is increasing interest in concurrent global development regardless of site of origin of the investigational compound. Whether "bridging" data from one jurisdiction to the other, or planning a concurrent global development program, multi-national programs require thoughtful design and execution.
Dr. Ruckle began as a Principal Investigator for Japanese-Caucasian bridging studies in July, 1998, as the E5 guidelines were first approved, and has performed over 50 bridging studies for Japanese registration since, including studies allowing concurrent development in Japan, the US, and the EU. Study experience encompasses a wide variety of compounds, clinical indications, and study designs. Coupled with liaisons in Japan, our proven track record prepares us to assist in this dynamic arena.
