Page 10 - 2017食品藥物管理署年報(英文版)
P. 10

上市前把關














                  Source Management &                                            Registration
                  Manufacturing Control
                  Food businesses management                                     Specific food products (health
                  (Registration/ GHP/ HACCP                                      foods, food additives etc.)
                  mandatorily conduct tests/ food                                Medicinal produts
                  safety monitoring plan/ traceability                           Medical devices
                  system)                                                        Medicated cosmetics
                  PICS/S GMP                    Pre-market
                  Cosmetics manufacturing &
                  management
                                                     control

                  上市後監控





        Product Life Cycle
                                              Post-market

                                             Surveillance

                   Distribution                                                  Customers
                   Management
                   Food GHP Inspection                                           Information transparency
                   GDP Inspection                                                Risk communication
                                                                                 Food poisoning,
                                                                                 unanticipated reaction report
                                                                                 Food safety foundation
                                                                                 Adverse medicinal product/
                                                                                 adverse event report
                                                                                 Adverse cosmetics event
                                                                                 report











                   Product               Distribution inspection
                                         Advertisement/Labeling
                   Quality Surveillance inspection
                                         Complaints report
                                         Warnings collection
                                         Medicinal product safety
                                         surveillance
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