The ICH E5 Guideline was introduced in February 1998 and subsequently implemented by the regulatory authorities of the USA, EU and Japan. The purpose of this guideline is to facilitate medicine registration among the ICH regions by recommending a framework for evaluating the impact of ethnic factors on a drug’s safety and efficacy while minimising clinical trial duplication.

Since clinical trials are arguably the most complex, costly, time consuming and resource intensive aspect of drug development, this guideline is expected to have a significant impact on the pharmaceutical industry. A survey of companies from the three regions, which was conducted by CMR International in 1997, indicated that this guideline is also expected to have positive effects in terms of reductions in clinical trial patient numbers in Japan, as well as reducing costs and development times.

Companies have expressed concern that there has been conservative interpretation in the implementation of this guideline in Japan – the second largest pharmaceutical market in the world. This is clearly an important issue to address, especially in light of the radical changes in the regulatory and clinical development environments that have taken place in Japan in recent years.

A 17-page questionnaire was developed comprising of 35 questions in five sections based on background research and input from experts. The questionnaires were sent to 45 international companies (2001) and achieved a 70% response rate (including 9 of the top 12 companies by R&D expenditure in 2000) of which 17 companies were able to provide adequate data. The data has been analysed qualitatively and quantitatively and a full report of the study was sent to all participant companies. Key survey results are outlined in this briefing.