Central Pharmaceutical Affairs Council CPAC

The Japanese regulatory authority is the Ministry of Health and Welfare (MHW) and the Pharmaceutical and Medical Safety Bureau (PSMB) is responsible for the promulgation of national and international guidelines in the form of Notifications. Guidelines are available on the Internet web-site of the National Institute of Health and Science (http //www.nihs.go.jp). The MHW has not issued specific guidance on the development of chiral drugs, but has nonetheless responded to the enantiomer-versus-racemate scientific debate. The attitude of the MHW and its advisory body, the Central Pharmaceutical Affairs Council (CPAC) is discussed in two articles by Shindo and Caldwell published in 1991 and 1995 [17, 18]. The latter paper analyzes the results of a survey of the Japanese pharmaceutical industry which sought responses on chirality issues. 

When a sponsor files a new drug application, PAB refers it to the Central Pharmaceutical Affairs Council (CPAC), which is made up of outside medical and scientific experts. A subcommittee of CPAC s Committee on Drugs performs the bulk of the review, although the full Committee as well as CPAC s Executive Committee also approve the subcommittee s findings. CPAC sends its recommendation to the Minister of Health who formally grants approvals.33... 

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. 

The Pharmaceutical Affairs Bureau, with the assistance of the Central Pharmaceutical Affairs Council (CPAC) and the Organization for Adverse Reaction Drug (ADR) Relief, Research and Devel-... 

AppHcations for approval of new drugs and medical devices are referred by PMSB to the Central Pharmaceutical Affairs Council (CPAC) to obtain its recommendation. The CPAC, in turn, is advised by the Pharmaceutical and Medical Devices Evaluation Center (PMDEC), an expert body organized in July 1997 to evaluate the quality, efficacy, and safety of medical products administered to humans. Specific authority within PMSB to approve recommendations received from CPAC regarding the discrete aspects... 

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