This presentation gives an idea of the regulatory systems of India and Japan, the functions performed by them as well as their various divisions, the complexities in their structure as well as the procedures for marketing of an approved drug and for clinical trials. The scope of this presentation is limited to the structural organization of both the regulatory bodies. NOTE - This presentation was made as part of an assignment for a Course PME 542 (Regulation and Compliance in the Pharmaceutical Industry) at Stevens Institute of Technology, Hoboken, New Jersey Prepared By - Kuldeep Badoniya

1. Prepared By -
Kuldeep Badoniya
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9. Drug Controller
General
Head Quarter
New Drugs
Imports
Zonal Office (4)
Gmp Audits
Coordinators
with states
Sub Zonal Office
(2)
Gmp Audits
Coordinators
with states
Port Office
Import
Export
Laboratory
Testing of
samples
Validation of test
protocol

11. STATE DRUG
CONTROL
ORGANIZATION
DRUG
CONTROLLER/COM
MISSIONER
DEPUTY DRUG
CONTROLLER
DRUG INSPECTOR
SUPPORTING STAFF
DRUG TESTING
LABORATORY
GOVT. ANALYST
ANALYST
SUPPORTING STAFF

19. Organizational
Chart of MHLW

22. Organizational
Chart of PFSB
and PMDA

24. Procedure
for
Approval
and
Marketing
of a New
Drug