In 2001, CMR International conducted a study among pharmaceutical companies to evaluate their experience with regulatory authorities in Asia Pacific regarding the acceptance of foreign clinical data and adoption of the International Conference on Harmonisation (ICH) E5 guideline.

Two-thirds of the survey respondents are currently conducting or planning to conduct bridging studies as defined by ICH E5, some of which have been actively requested. The expected hurdles of using E5 in this region include resource constraints, misinterpretation, lack of Good Clinical Practice (GCP) compliance and lack of authorities’ experience.

Anticipated benefits of using E5 include minimum duplication of studies, faster approvals, better-defined, planned and efficient clinical development, and authority assurance that drug response is similar in local populations.

Most companies are in favour of Asia Pacific authorities implementing the ICH E5 guideline to facilitate the acceptance of foreign clinical data, providing there is scientific justification, replacing local clinical trials.