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2015 Annual Report
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Controlled
Drugs
Management
Medical
Devices
Management
Risk Assessment
Management and
Research Outcomes
Cosmetics
Management
Appendix
National
Laboratory and
Testing Network
Risk Communication
and Consumer
Protection
International
Cooperation and
Cross-Strait Exchange
Medicinal
Products
Management
Policy and
Organization
Food
Management
Different from consumer goods, medicinal products are highly regulated. In order to ensure public health,
the regulations of medicinal products need to be harmonized with international standards, as well as
simplified and integrated in review process. The source and distribution of medicinal products (including
active pharmaceutical ingredients) have to be regulated. Post-marketing surveillance is conducted to
ensure the quality and safety of medicinal products. In addition, investigation of illegal drugs and controlled
drug managements are taken to protect public safety.
The life cycle of medicinal products from research and development to market release includes basic
research, non-clinical studies, clinical trials, registration, manufacturing, and marketing. Every phase of this
life cycle must be compliant with various specifications ("GXP") via reviews, audits, and inspections, which
forms a comprehensive medicinal product life cycle management framework (Figure 3-1). For example, CTD
is used as the format for registration data, using stringent reviews as checkpoints to ensure the quality, safety,
and efficacy of medicinal products. GLP and GCP inspections are carried out during Non-clinical study
and clinical trail to ensure quality. Manufacturing processes are also audited for compliance to GMP. Where
necessary, pre-marketing and post-marketing inspections and compliance with GPvP may be executed to
achieve comprehensive drug life cycle requirements.
3
Section 1 Medicinal Product Regulations and Registration
Current status
Quality demands for post-market medicinal products prescribed by international laws become ever more
stringent every year, especially for post-marketing registration change management and the release of
emerging medicinal products (such as cellular and gene therapy products). Corresponding national law in
Taiwan is still lacking in these areas. Hence, TFDA continued to revise and formulate relevant management
specifications, at the same time reference global drug management trends and the management for
medicinal products that are high-risk or consumed by a specific population. Medicinal product registration
systems were established along with continuous revision of medicinal product management laws to
ensure consistent quality and efficacy of the medicinal products.
Medicinal Products Management
CTD
GLP
GCP
GPvP
GMP
：
Common Technical Document
：
Good Laboratory Practice
：
Good Clinical Practice
：
Good Pharmacovigilance Practice
：
Good Manufacturing Practice
Review
Site
Inspection
Assay
Basic research Non-clinical
Clinical trial
Registration Manufacturing Marketing
CTD: safety, efficacy, quality
GLP
、
GCP
GPvP
GMP
Test/analysis
Figure 3-1
Medicinal product life cycle management framework