Developing a new regulatory authority for Drugs and Medical Devices/CRDS-FY2007-SP-15
Executive Summary

We see striking progress in the recent life science, but the implementation of a clinical research on human beings is indispensable to use the achievements in medical practice. However, the clinical research now remains flat in Japan and the applications of new drugs and medical technologies have been delayed, making us a developing country with advanced medicine. This is a serious problem in Japan that has already entered an aging society and requires further upgrading of medicine.

There are several reasons why the clinical research in Japan is lagging behind. A particularly important issue is a problem of the review/approval system for drugs, medical devices and biological products. The review/approval for candidate substances as new drugs is an important work that is required to fully recognize uncertainty included in the medicine itself, make scientific evaluation of the safety and efficacy, approve the drug as new medicine and ensure that the public can quickly receive the benefit. For this purpose, the standards and procedures of the review/approval have been continuously examined and improved around the world. However, compared with such global trend, the improvement of the review/approval system in Japan is clearly lagging behind other countries.

This proposal proposes the following measures to the government and related organizations in order to reform the review/approval system for drugs, medical devices and biological products.

1) Revision and improvement of legislative systems for the review/approval
To unify the management of regulations and review when carrying out a clinical research using candidate substances for new drugs, etc.

2) New establishment of Drug Agency (provisional title)
To revise the current system in which the review and approval organs for clinical research and the approval are separated, integrate the review-related sections (e.g. Evaluation and Licensing Division) of the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) and improve the system as the Drug Agency (provisional title)

3) Strengthening of human resources involved in the review/approval
To promote the development and strengthening of human resources in the regulatory authorities through the thoroughness of job principles and revitalization of personnel exchanges and penetrate a new concept of regulatory science into the people in both the review and development sides.

The introduction of these measures enables safer and more effective medicines to quickly spread in the society and achieve the improvement of national health and medical care. The progress of science and technology in the life science filed, development of healthcare industry in Japan and upgrading of Japan’s international contribution can be also expected.