Japanese Institutions and Regulatory Authorities

Japanese institutions and regulatory authorities are organized in a rather complex way, with a few institutions and regulatory authorities being responsible for the oversight of regulating pharmaceuticals, and a few others, purely for developing pharmaceuticals.

The overall regulator of the Japanese institutions and regulatory authorities is the Japanese Ministry of Health, Labor, and Welfare (MHLW), which is an offshoot of the Ministry of Health and Welfare (MHW), with which the credit for framing and implementing most of the current regulations lies.

Japanese institutions and regulatory authorities for regulating pharmaceuticals

The Pharmaceutical and Food Safety Bureau (PFSB), which comes under the MHLW, is the pharmaceutical regulatory authority of Japan. This body is the one that takes decisions relating to application approval.

In addition, Japanese institutions and regulatory authorities consist of two other bodies that work with the pharmaceutical industry on a day-to-day basis. These are:

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Although it is admitted that the organization of Japanese institutions and regulatory authorities in such a manner is rather confusing and an effort is underway to merge these three institutions; as of now, this is yet to materialize. There has been some ongoing movement towards creating a superstructure of these three Japanese institutions and regulatory authorities, creating an FDA-like body.


Japanese institutions and regulatory authorities in relation to development of pharmaceuticals

Japanese institutions and regulatory authorities in relation to development of pharmaceuticals are organized in the following manner:

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