In an effort to speed the approval process for foreign drugs in Japan, hospitals at six national universities, including Tokyo University, have come to an agreement to conduct clinical trials jointly. Under this agreement, called the “University Hospital Clinical Trial Alliance,” foreign pharmaceutical companies will no longer need to approach these institutions individually to conduct clinical trials. Rather, the group will determine which institution is best suited to conduct the company’s clinical trials. It will also simplify and standardize testing procedures and coordinate activities such as volunteer recruitment. The alliance intends to make itself an attractive candidate for international trials undertaken by major drug companies. It is the first grouping of its kind to involve such renowned institutions or to have such a broad scope of cooperation.
This initiative is a much-needed enhancement of Japan’s drug approval process, among the slowest of all industrialized nations. It takes an average of almost four years for a drug already released elsewhere to gain approval in Japan. As a result, in 2004, about 30 of the 100 worldwide top-selling drugs were not available there. Both medical regulators and medical professionals in Japan have come to see the slow approval process as a problem in need of urgent attention.