Page 33 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

Chapter 2. Medicinal Products Management

Unlike general consumer products, medicinal products are closely associated with the health
and lives of fellow citizens. Medicinal products are therefore subject to strict regulations and must
acquire approved drug permit licenses from the central health authority before they may be sold
on the market. TFDA is constantly reviewing and strengthening medicinal product monitoring
systems to ensure drug use safety amongst the general public by revising pharmaceutical laws
and harmonizing them with international standards, simplifying review processes and unifying
management systems, monitoring the sources, distribution, and quality of drug manufacturing,
prohibiting illegal drugs, and enforcing controlled drug management measures. Part II - Key Administrative Results Medicinal Products Management
Medicinal product life cycle from research and development to market release include
these steps: fundamental research, non-clinical studies, clinical trials, license applications,
manufacturing, and market distribution. Reviews, audits, and inspections were conducted at each
step to ensure compliance with various speci?cations (GXP), forming a comprehensive medicinal
product life cycle management framework (Figure 2-2-1). For example, GLP and GCP audits
must be carried out to ensure testing 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-marketing 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 Clinical Permit Production and Marketing and
study study trial applications manufacturing release
Review CTD : Safety, Efficacy, and Quality

GLP 、GCP GPvP
Site audits
GMP

Inspection CTD : Inspection / analysis
CTD ：Common Technical Document
GLP ：Good Laboratory Practice
GCP：Good Clinical Practice
GPvP：Good Pharmacovigilance Practice
GMP：Good Manufacturing Practice

Figure 2-2-1 Medicinal product life cycle management framework

Section 1. Medicinal Product Regulations and Product Review

Current status
Post-marketing quality demands of medicinal products prescribed by international laws are
becoming increasingly stringent every year, National laws must therefore maintain adequate
alignment. TFDA has therefore continued to inspect, revise, and formulate relevant management
specifications, reference global trends in drug management, and direct management efforts
towards medicinal products with higher levels of risk or those consumed by a speci?c population.
Medicinal product registration and management systems were established along with continuous
revision of medicinal product management laws to ensure consistent product quality and ef?cacy.
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