Page 16 - 2023 Taiwan Food and Drug Administration Annual Report
P. 16
2023 Taiwan Food and
Drug Administration
Annual Report
Section 4 manufacturing to post-marketing, etc., various
good operating practices must be followed.
Overview of Drugs Unlike ordinary commodities, medicinal
and Controlled products can only be sold on the market after
Drugs Management having obtained the marketing authorization
issued by the central competent authority.
I. Medicinal products TFDA continues to reinforce the quality
management framework management policy for the full life cycle of
drugs (Figure 1-5) through the harmonization
In the life cycle management of medicinal with international regulations, establishment
products, from product development, of various mechanisms for priority review,
preclinical studies, clinical trials, marketing digital drug management, standardization of
authorization application, production/ quality and safety supervision, inspection of
Product Pre-clinical Clinical Pre-market Production Post-market
Development Study Trial Application
Pre-market Review Post-market Surveillance
Good Laboratory Good Clinical Registration Post-market Change
Practice (GLP) Practice (GCP)
Production Source Control Clinical Trial Protocal
Review
Good Manufacturing Practice (GMP)/Good Tissue Practice (GTP)
Risk Management Plan
General / Case-Specific Consultation Defective product
ADR : Adverse Drug Reactions & ADR reporting
Regulations for the Management
of Drug Safety Surveillance
Good Distribution Practice
Regulations Governing the
Trace and Track System for
Medicinal Products
Good Pharmacy Practice (GPP)
Pharmaceutical Care / Safety
Medication Education
Figure 1-5 Full Life-cycle Management Structure for medicinal products
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