Japan drug approval

Currie, W.J.C. (1995). New Drug Approval in Japan. Parexel, Waltham, MA. 

The Pharmaceutical and Medical Device Agency (PMDA) of the MHLW is responsible for drug approval in Japan. 

Drug approval processes go through IND and NDA procedures in Japan. The MHLW of Japan has set up the Pharmaceutical and Medical Device Agency (PMDA), which provides technical consultation services for clinical trials. There are four types of consultations before IND, at the end of Phase II studies, before NDA, and consultation on individual protocols. 

An NDA submitted to the MHLW is reviewed by the PMDA. PMDA personnel have the authority to inspect the drug manufacturing facility and clinical trial sites to assess comphance. In the process, the PMDA consults the Pharmaceutical Affairs and Food Sanitation Council (PAFSC). Results of the review are forwarded to the Pharmaceutical and Food Safety Bureau (PFSB), which prepares the final approval through the Minister of the MHLW. Figure 8.10 shows the drug approval process in Japan. The procedure for manufacturing and distribution of drugs for overseas manufacturers is presented in Fig. 8.11. 

Drug Approval and Licensing Procedures in Japan 2001, Jiho Co., Ltd., Tokyo. 

The Pharmaceuticals and Cosmetics Division (Koseisho) of the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare (MHW) is the regulatory body in Japan. Also in Japan there have been clear changes in the drug approval system, mainly inspired by ICH. One of the most important recent changes is that, under certain conditions, it is now possible to use also foreign data for the approval of new dmgs in Japan. 

The Ministry of Health, Labour and Welfare is the governmental body responsible for enacting legislation for pharmaceutical affairs. The regulation of clinical trials and new drug approval in Japan is based on the Pharmaceutical Affairs Law and related ordinances. The objective of the Ministry is to secure a safe medical environment through a consolidated structure of accurate reviews of pharmaceuticals and medical devices and postmarketing safety measure implementation. 

Drug approval and licensing procedures in Japan 1989," Yakugyo Jiho Co. Ltd., Kanda, Chiyoda-ku, Tokyo 101, Japan. 

Neither version of this dye is currently approved in Japan for use in drugs because of a lack of precedent. It would probably be possible to obtain approval in Japan if a manufacturer included one of these colorants in a new drug application and provided adequate safety data to convince Japanese regulators that the colorant is safe. However, in practice, most companies avoid using colorants that lack a precedent of previous use in Japan because this will usually delay drug approval. 

Table 1. Number of NCEs approved by the year in Japan. Source Handbook on Application for New Drug Approval, Yakugyo Jiho Co., Ltd. 

Natio C, Yasuhova H. 1993. Retrospective survey of pharmacokinetics dosage of 80 drugs approved in the EC, Japan, and US . E5 Workshop Reports, ICH-2, Orlando. 

Russell KB, Bremer M. New Drug Approval in Japan. Waltham, MA PAREXEL International, 2002. The authors provide a thorough analysis of Japan s reorganized regulatory agency structure, its streamlined NDA process, and its rapidly evolving policies toward the acceptance of foreign clinical data. 

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