Page 86 - 2017食品藥物管理署年報(英文版)
P. 86
Methods
Monitoring:
Passive
‧Reporting system
‧Safety report during new drug surveillance period
Plans Strategies Active
Collect information Passive Surveillance ‧Domestic/International product alerts monitoring
and make risk- Active Surveillance ‧Regular/Periodic factory inspection
management plans ‧Data application of interdepartmental food IT system
Re-Review Analysis
Re-evaluation
‧Drug safety re-evaluation
‧Drug active surveillance
‧Oil traceability analysis
‧Import food risk analysis
Control Outcomes Control Measures
Risk control:
‧20 medicinal products have adopted risk control ‧Amend package insert
measures, e.g. NSAID anti-inflammatory drugs to ‧Restrict the use
control cardiovascular risks, the 3rd-4th genera-
tion of contraceptives to control thrombotic risks, ‧Implement risk management plan
bisphosphonates to control osteonecrosis of jaw ‧Recall
and atypical fracture risks ‧Withdraw from the market
‧35 medical devices have taken risk control
measures, e.g. becoming prioritized factory ‧Strengthen audition and monitoring
inspection or GMP/QSD review documents,
prolong monitoring, supply data, becoming safety
surveillance target
‧Use data exploration and statistical analysis to
screen high-risk food
Risk communication:
‧Issue 12 drug risk communication letters
‧4 newsletters of medicinal product safety
Early Warning Monitoring and Risk Management
