Module 1 2021

28/06/2021

PMDA

PMDA (Pharmaceutical and Medical Device Agency)

 Consultations

 Implementation of work such as review of CTN/JNDA

 Interface with applicants during review

 GCP/GMP Inspections

 Document compliance review

Distribution to third parties is not allowed

15

PMDA Structure

Office for Promotion of regulatory Sciences Office of General affairs/ Finance/Planning

Chief Management Officer

Auditor

Office of Quality Control Office of Safety I, II Office of Conformity Audit Office of Medical Devices I, II Office of OTC/Generic Drugs Office of Biologics I,II Office of New Drug I - V Office Review Administration Office of Review Management Office of Relief Funds Office International programs

Sr Ex. Director

Auditor

Chief Relief Officer

Chief Executive

Center Review Director

Ex. Director

Ex. Director

Chief Safety Officer

Inspection Office

Distribution to third parties is not allowed

16

8