Central Pharmaceutical Affairs Council

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. 

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. 

After comments are reviewed and changes are made, the revised draft is reviewed by the Committee on the Japanese Pharmacopeia and then by the Executive Committee of the Central Pharmaceutical Affairs Council before it is submitted for publication in the JP. 

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. 

An advisory body the central Pharmaceutical Affairs Council, involved in drug evaluation. 

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-... 

Planning Division. This division coordinates all activities of the PAB, enforces the Pharmaceutical Affairs Law, manages questions related to the Central Pharmaceutical Affairs Council, and provides guidance and supervision to the Drug Organization. Two offices are attached to the Planning Division ... 

A first review is carried out by MHW officers regarding the format, contents and quality (source data should be provided upon request). A hearing can take place after this preliminary review and instructions are given to the pharmaceutical company to amend or complete the application. Samples of the active principle might also be requested, for analytical control by the National Institute of Hygienic Sciences. The application is then transferred to the Central Pharmaceutical Affairs Council. 

The safety information collected on a drug is assessed by the Central Pharmaceutical Affairs Council (the Adverse Reaction Committee) and when necessary the MHW instructs the manufacturer to take measures such as ... 

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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