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Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Japan regulatory guidelines

The pharmaceutical regulatory authority of Japan is the Pharmaceutical and Food Safety Bureau (PFSB) of the MHLW. This is where the decision for application approval is formally made. Two other bodies deal with the pharmaceutical industry on a day-to-day basis. The Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), usually known as “The Center,” is the actual decisionmaker for approval of new drug applications (NDAs).

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European Industrial Pharmacy, Bioanalysis Journal

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