The issues to be considered in global drug development

Drug review procedures and drug development strategies are changing rapidly due to “ The International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use ” (ICH), which was initiated in 1990 [1]. The ICH seeks to improve the efficiency of the development and review processes for promising new drugs by unifying necessary documentation and the associated formats for new drug applications (NDA) to regulatory agencies. In particular, the E5 guideline regarding ethnic factors in the acceptability of foreign clinical data has a significant impact on a new drug’s development by allowing for the extrapolation of foreign clinical data as part of an NDA submission to the regulatory agency in a new region [2]. In consideration of intrinsic and extrinsic factors in new regions, a sponsor is required to conduct a small clinical trial called a “bridging study” in the new region to ensure that the profile of the drug derived from the foreign clinical data is applicable to a new region. The guideline provides two potential advantages: patients have quicker access to new therapies, and the sponsors can save money and time by avoiding a full-scale clinical trial in a new region when developing a drug. The E5 guideline opens the door to simultaneous global drug development by specifying one global protocol for NDA submission in each region, as long as the sponsor has an appropriate bridging strategy. Many international pharmaceutical companies have responded by merging and establishing alliances in order to take advantage of global drug development possibilities and to speed global marketing of their products [3]. Regulatory agencies also have had to adjust to the realities of extrapolating foreign clinical data to their countries. The May 2001 symposium “APEC Network of Pharmaceutical Regulatory Science-APEC Joint Research Project on Bridging Study” was held in Taipei, Taiwan to discuss implementation of bridging studies among the regulatory agencies, academia and industries of APEC economies. Globalization of drug development requires at least two conditions: a protocol to be reviewed by a regulatory agency before conducting a clinical trial in each region, and high