(2002; 166 pages)
The harmonization process of ICH - philosophy, process and future
Dr Yasunori Tsuruta, Japan
Much has been achieved by ICH so far, including some 40 technical guidelines on quality, safety, and efficacy, which provide the scientific basis for the testing and evaluation of new drugs. Since the fourth Conference, ICH has moved to more regulatory aspects, e.g. the Common Technical Document (CTD), MedDRA, gene technology, and establishing the Global Cooperation Group to offer direct assistance to non-ICH countries.
The ICH guidelines have contributed to the timely introduction of new products in Japan. ICH triggers changes in the regulatory environment in each region, allowing science-based discussion with industry and drug regulatory agencies. The improved quality of the data included in new drug applications after the implementation of ICH GCP and ICH E5 (concerning ethnic factors) means that the data are more widely acceptable, regardless of their origin. This facilitates acceptance of foreign clinical data.
The tighter control of clinical trials has implications for resources, including research funds, human resources, etc., and for incentives to perform such trials in Japan. ICH E5 was implemented in Japan in 1998, replacing the former guideline which required clinical trials to be performed in Japan for submissions for new drug applications.
ICH E5 will potentially allow more scope for clinical trials to be conducted in other parts of the world, by allowing a bridging study where data are available from foreign clinical trials. In Japan, the Ministry of Health and Welfare developed a system of consultation to facilitate such a study. Although still at an early stage, experience with bridging studies is gradually being accumulated.
The Common Technical Document is another notable achievement of ICH. NDA submissions should conform to CTD requirements, in order to improve communication among regulators.
With synchronized submission review, it is expected that synchronized approval of new drugs by the three regions will be achieved. Synchronized launch of new drugs may imply a wider exposure to new drugs in a short period of time. Regulators and industries should work together on mechanisms to ensure a safe rollout of new drugs and early detection of adverse reactions.
It is of utmost importance for ICH to maintain its current momentum and to take initiatives on newly emerging issues in order to ensure timely access to new drugs for patients around the world, and to cope with the changing environment.