Japan Plans to Change Rules on Clinical Trials

The Japanese government has announced that it plans to change the clinical trial requirements for new drug approval in Japan. In a March 2006 interview, Akira Miyajima, the Chief Executive of the Pharmaceutical and Medical Devices Agency (PMDA), stated that the PMDA is considering issuing new guidelines that would reduce the amount of clinical data on ethnic Japanese required before a new drug may be considered for approval. If implemented, these new rules could expedite the approval of new drugs in Japan, which is known to be a very lengthy process.

Currently, any new drug requesting approval by the PMDA must first undergo clinical trials, in which a certain minimum proportion of subjects must be ethnic Japanese. This requirement is in place because of concern for the potential variance in a drug’s effect depending on the subject’s ethnicity. This is one of the reasons that the Japanese government is wary of accepting significant foreign clinical data for approval of a new drug.

Mr. Miyajima has suggested that the PMDA may consider accepting data on other Asian subjects in lieu of requiring data on people of Japanese descent only. In addition, the relaxed clinical data requirements could be supplemented with stronger post-market surveillance to monitor any side effects of new drugs. Mr. Miyajima stated that the PMDA hoped to issue the new guidelines within the next year.