2nd DIA Cardiac Safety Workshop in Japan

The ICH Guidelines for nonclinical and clinical cardiac safety assessments in drug development, S7B and E14, respectively, were released in 2005 and swiftly implemented in the US and EU. The Japanese Ministry of Health, Labor and Welfare (MHLW) and its Pharmaceuticals and Medical Devices Agency (PMDA) announced the adoption of ICH E14 guideline in Japan in October 2009, allowing for a one year of ‘grace period’ for consultations and the development of industry compliance strategies. The guideline formally came into force on 1st November 2010, from which
date submissions of New Drug Application (NDA) in Japan are required to  include the E14 cardiac safety data.

The implementation of the ICH-E14 cardiac safety guidance in Japan was somewhat hindered by shortage of domestic clinical facilities, professional services and clinical experience required to support the new requirements. In addition, questions relating to possible ethnic differences and the extrapolation of foreign clinical data, including the E14 mandated Thorough QT (TQT) studies, into Japanese population remain largely unanswered, further impacting the harmonization of the drug development process across the ICH regions. Yet, with the active support of PMDA the Japanese pharmaceutical industry has embraced the new cardiac safety paradigm and this year launched the fi rst formal E14 Thorough QT studies.

The 2nd DIA Cardiac Safety Workshop in Japan will continue to address the key scientific, clinical and regulatory issues of implementation of ICH-E14 in Japan. The meeting will bring together experts from multiple disciplines and is intended to facilitate an open and productive dialogue between regulatory, industry and academic delegates.