Page 13 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report Chapter 1. Management Overview

amongst the general public by revising pharmaceutical laws and harmonizing them with
international standards, establishing expedited review processes, monitoring the sources,
distribution, and quality of drug manufacturing, thus prohibiting illegal drugs, and
enforcing controlled drug management measures.
Medicinal product life cycle from research and development to market release

include following steps: fundamental research, non-clinical studies, clinical trials,
registrations, manufacturing, and market distribution. Reviews, audits, and inspections
were conducted at each step to ensure compliance with various specifications (GXP),
forming a comprehensive medicinal product life cycle management framework (Figure
1-3). For example, GLP and GCP inspections will be carried out to ensure study quality
during non-clinical studies and clinical trial phases. Manufacturing processes shall be
audited for compliance with GMP. Where necessary, pre-market release inspection and
analysis as well as post-market sampling tests shall be carried out to ensure continuing
compliance to Good Pharmacovigilance Practice (GPvP). These measures will improve

measures for medicinal product quality and safety surveillances and achievement of all
medicinal product life cycle management objectives.

Fundamental Non-clinical Permit Production and Marketing

research study Clinical trial 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 Inspection
GDP ：Good Distribution Practice Review

Test
Figure 1-3 A comprehensive medicinal product life cycle management framework

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