Drug registration in Japan

The Japanese are the greatest consumers of pharmaceutical products per capita in the world. The Ministry of Health and Welfare in Japan has overall responsibility to implement Japanese pharmaceutical law. Within the department is the Pharmaceutical Affairs Bureau (PAB), which exercises this authority.

There are three basic steps in the Japanese regulatory process:

• approval ('shonin') must be obtained to manufacture or import a drug;

• an official price for the drug must be set.

The PAB undertakes drug dossier evaluations, a process that normally takes 18 months. The approval requirements/process for pharmaceuticals (including biopharmaceuticals) are, in broad terms, quite similar to the USA. The PAB have issued specific requirements (Notification 243) for submission of recombinant protein drugs.

Applications are initially carefully checked by a single regulatory examiner to ensure conformance to guidelines. Subsequently, the application is reviewed in detail by a subcommittee of specialists. Clear evidence of safety, quality and efficacy are required prior to approval.

In addition, the Japanese normally insist that at least some clinical trials be carried out in Japan itself. This position is adopted due to, for example, differences in body size and metabolism of Japanese, compared with US and European citizens. Also, the quantity of active ingredient present in Japanese drugs is lower than in many other world regions. Hence, trials must be undertaken to prove product efficacy under intended Japanese usage conditions.

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