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In parallel with the review, drugs containing a new ingredient are also referred to the National Institute of Hygienic Sciences (NIHS) or the National Institute of Health (NIH). Among the functions of the NIHS is the testing and analysis of drugs, whereas the Japanese NIH conducts tests on specifications for antibiotics and biological products and have strong representation on the committee on antibiotic products. |
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A drug is defined as new if at the time of application for a manufacturing or import approval it is designated as different (by chemical structure of the active ingredient, desired indication, or planned dosage, etc.) from those already approved in Japan. The significance of the definition is that new drugs are subject to postapproval clinical investigation. Applications to manufacture or import a drug must be made through the pharmaceutical sections of the prefectural government office of the district where the business is situated. For all drugs, except nonprescription medications with government defined approval standards and some raw materials the prefectural governor transmits the application to the MHW for evaluation. |
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Each of the four subcommittees of CPAC for new drugs meet twice monthly whereas the other subcommittees generally meet monthly. A subcommittee will deliberate on one to three drugs during any one session, and a product is likely to be reviewed on several separate occasions. Only when the subcommittee is satisfied with a product's quality, safety, and efficacy will it proceed to the next stage in the review. An NCE passes to a special committee on new drugs that meets once every 3 months and reviews 10 to 15 products per session. Products that pass the scrutiny of these special committees advance to the executive committee, which usually meets 1 month after the special committee session. The most senior committee in the decision tree, the executive-committee membership is draw from senior or former members of Japan's leading pharmaceutical, medical, scientific, and health department institutions. It is responsible for making recommendations to the Minister of Health and Welfare. The number and type of subcommittees and committees are shown in Figure 2. The therapeutic areas of responsibility of each of the four subcommittees for new drugs is shown in Table 1. |
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When the MHW has approved a drug the sponsor is notified by its Prefectural Government Office. This involvement of the Prefectural Office is to ensure its awareness of the application since it shares responsibility with the Inspection and Guidance Division of the PAB, under whose oversight it is charged with ensuring the manufacturer's adherence to Japanese Good Manufacturing Practice (GMP). The GMP was incorporated into the regulations and has been enforced since September 1980. The Drugs Division of the PAB is responsible for monitoring compliance with Good Clinical Practice (GCP). As noted, the Lyakuhin Kikou now has responsibility for monitoring compliance with GLP; however, when conducting inspections to ensure adherence |
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