Central Pharmaceutical Affairs Council, Japan

In Japan, if the drug product contains an excipient with no precedence of use in that country, then the quality and safety attributes of the excipient must be evaluated by the Subcommittee on Pharmaceutical Excipients of the Central Pharmaceutical Affairs Council concurrently with the evaluation of the drug product application. Precedence of use means that the excipient has been used in a drug product in Japan, and will be administered via the same route and in a dose level equal to or greater than the excipient in question in the new application. 

Marketing and manufacturing of drugs in Japan is under the control of the Ministry of Health, Labor and Welfare (MHLW). The MHLW has set up an advisory body, the Central Pharmaceutical Affairs Council (CPAC), to advise the ministry from a scientific viewpoint. There are three requisites in the approvals of drugs in Japan ... 

An NDA submitted to the MHLW is reviewed by the OPSR. OPSR personnel have the authority to inspect the drug manufacturing facility and clinical trial sites to assess compliance. Results of the review are forwarded to the Pharmaceutical and Medical Devices Evaluation Center (PMDEC), which prepares the approval procedures. The Central Pharmaceutical Affairs Council (CPAC) gives the final approval. Figure 8.10 shows the drug approval process in Japan. 

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