Page 16 - 2021 Taiwan Food and Drug Administration Annual Report
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WULDOV FOLQLFDO WULDOV PDUNHWLQJ DSSOLFDWLRQ timely manner. These measures would also
PDQXIDFWXULQJ WR PDUNHWLQJ DQG YDULRXV facilitate the development of biotechnology
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tries and the government.
TFDA continues to reinforce the quality
II. Controlled drug management
management policy throughout the drug framework
life-cycle (Figure 1-5) through harmoniza- Controlled drugs refer to addictive narcotic
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GLJLWDO GUXJ PDQDJHPHQW VWDQGDUGL]DWLRQ that require regulations and may only be used
RI TXDOLW\ DQG VDIHW\ VXSHUYLVLRQ EDQ DQG for medical and scientific purposes. If used
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etc. All of these measures are ensuring the According to the “Controlled Drugs
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those in need can obtain the medicines in a
Product Pre-clinical Clinical Listing Production Marketing
Development Testing Trial application
Good Laboratory Good Clinical Pre-marketing Post-market
Practice (GLP) Practice (GCP) Review Surveillance
Approval Post Marketing
Change Control
TFDA / Institutional
Review Board (TFDA/IRB)
Production Source Control Good Manufacturing Practice (GMP)/Good Tissue Practice (GTP)
Product Risk Control Risk Evaluation & Mitigation Strategies / Risk
Management Plan (REMS/RMP)
General / Case-Specific Consultation ADR & defective product
reporting
Good Pharmacovigilance
Practice (GPvP)
Good Distribution Practice (GDP)
Regulations Governing the
Trace and Track System for
Medicinal Products
Good Pharmacy Practice (GPP)
Pharmaceutical Care / Safety
Medication Education
Figure1-5 Life cycle management structure of drugs
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