19th New Drug Evaluation Division Information Meeting

JKS Newsletter
June 2004

Image of the Japanese title of the meeting

The topics of the meeting held on May 20 cover the new Pharmaceuticals and Medical Device Agency (PMDA) - which started operations in Japan on April 1, 2004 are discussed in details and illustrated 
View the full program


For the first time in English a full report of the meeting

The 19th meeting was entirely focused on the newly inaugurated Pharmaceuticals and Medical Device Agency (PMDA), with the key presenters senior officials from the agency. The JKS report featured here contains two parts: summary of the main presentations and illustrations on PMDA


 1. Current Trends in the Approval Examination

2. Clinical Trial Consultations in PMDA

3. Drug Safety Measures of PMDA

4. New Approval Review System of PMDA

.List of illustrations:

Table 1. New categories of consultations
Table 2. Present Consultation Categories (for new medicinal products)
Table 3. Fees for new drug clinical trial consultations
Flowchart 1. Procedure for consultation in PMDA
Flowchart 2. Flow-chart of the review work by PMDA
Table 4. Department in charge of clinical trial consultation

The 26-page report is provided for corporate customers under either single user or enterprise-wide use licenses.

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