Page 13 - 2018食藥署年報(英文版)

Section 2 Overview of Drugs and Cosmetics Management

In order to promote the safety and quality of medicinal products, and to facilitate the
development of the biotechnology industry, TFDA established a regulatory environment in line
with international trends to respond to global market development and law harmonization. At the

same time, TFDA continued on advancing drug review capacity and impoving product shortage
reporting/assessment system; activate search potential cases and establish counseling projects to
expedite the production of innovative medical devices and medicinal products in Taiwan, and thus
achieve a stable supply chain and provide industry consultation/counseling services and complete
product review system. TFDA also strengthened product manufacturing, distribution management,
and quality surveillance, to establish medicinal product traceability and follow-up system and
accomplished an overall safety and quality control of medicinal products and cosmetics.

Moreover, TFDA is committed to diversify pharmaceutical affairs services, and create a
correct and supportive educational environment to increase the awareness of safe drug, medical
device, and cosmetics use of the public.

1. Medicinal products management framework

The medicinal product life cycle from research and development to market release include
the following steps: fundamental research, non-clinical studies, clinical trials, license applications,

manufacturing, and market distribution. Each step should be in compliance with various

Fundamental Non-clinical Clinical trial Permit Production and Marketing

research study applications manufacturing and release
Review CTD: Safe, Effective and Quality

GLP、GCP、GTP GPvP
Inspection
GMP／GDP

Test Analysis

CTD ：Common Technical Document
GLP ：Good Laboratory Practice
GCP ：Good Clinical Practice
GTP ：Good Tissue Practice
GPvP：Good Pharmacovigilance Practice
GMP ：Good Manufacturing Practice
GDP ：Good Distribution Practice
Inspection
Review
Figure1-3 A comprehensive medicinal product life cycle
management framework Test

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