Abstract

With increasing global acceptance of the provisions in various guideline documents resulting from the International Conferences on Harmonization (ICH) and the advent of regulatory changes in Japan/Asia Pacific region, it has become possible to integrate the requirements for pharmaceutical product registration in this region into global development programs. Multinational research-based pharmaceutical companies have begun global drug development programs more efficiently providing patients throughout the world with safe and efficacious new treatments in the shortest possible time. ICH E5 (Ethnic Factors in the Acceptability of Foreign Clinical Data) formalizes the opportunity to use “bridging” for registration of global pharmaceutical products, with clinical science as the driver.

The bridging package should be determined by what is needed to show similarity between patients in Asia/Japan and other regions. Similarity of clinical response or surrogate variable, supported by clinically meaningful argument is more relevant to treating patients than proving pharmaceutical bioequivalence. New definitions of similarity by context of drug and indication require novel approaches like population pharmacokinetics and pharmacodynamics analyses and/or inclusion of native and expatriate Japan/Asia Pacific patients in pivotal studies. Global clinical studies have been successfully conducted in Asia, Europe and USA. The results obtained from these trials have been utilized for global registrations. Consequently, as bridging is bi-directional, the scientific basis and content of the strategy should be equally applicable to a mainly Asian/Japanese package being used for registration in the US and EU.

Drug Information Association (DIA); Hong Kong, China; November 2000

By Tamie Bergstrom, PhD, Ellick Wong, PhD, Ed Antal, PhD and Ted Grasela, PharmD, PhD