Pharmaceutical and Medical Devices Agency PMDA

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. 

Responsibility for regulatory review has been passed to an Incorporated Administrative Agency, the Pharmaceutical and Medical Devices Agency (PMDA). PMDA also intensively checks applications for GCP compliance and reliability compliance. Another important role of PMDA includes an advice to sponsors on clinical trials and on which result can be submitted at the time of a new drug application. 

The PFSB, the Health Policy Bureau, with the assistance of the PAFSC, and the Pharmaceuticals and Medical Devices Agency (PMDA or Kiko in Japanese) represent the managing authorities of Japanese pharmaceutical administration, in charge of reviewing drug application for approval, reexamination or re evaluation. 

The Pharmaceuticals and Medical Devices Agency (PMDA or Kiko in Japanese)... 

This study was supported in part by the Program for the Promotion of Fundamental Studies in Health Sciences (MPJ-6) of the Pharmaceuticals and Medical Devices Agency (PMDA). The authors thank Yakult Honshu Co. for generously donating SN-38 and SN-38 glucuronide, and Ms. Clue Knudsenfor her secretarial assistance. 

The Japanese regulatory process was revised in 2004, creating the Pharmaceutical and Medical Devices Agency (PMDA), and provisions relating to medical devices came into effect on April 1, 2005 [16], In Japan two submissions may be required a KIT Drug J-NDA submission and a separate Medical Device Certification the latter of these has to be filed with PMDA. It should be noted that the review timelines for KIT Drug and Medical Device Certification submissions... 

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) adopted ICH E14 in 2009, allowing a year s grace period before its full implementation in November 2010... 

PMDA Pharmaceuticals and Medical Devices Agency SET Sucrose breathing test... 

The main activities of the PMDA are to offer the pharmaceutical industry consultations with regard to clinical trial protocols and drug and medical devices development plans, to conduct new drug application review and to confirm the quality of the submitted data. The PMDA, or Drug Agency, is composed of 15 offices to conduct different services (see Figure 35.3). 

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