Page 61 - 2019食藥署年報(英文版)

TFDA tested at least 600 products and 96 products were recalled because of detecting with
1'0$ 1'($ RU 10%$ 7)'$ UHTXLUHG WKH PDQXIDFWXUHUV DQG GUXJ GHDOHUV WR VWULFWO\ IXO¿OO
self-management, evaluate the carcinogens that may be generated in the manufacturing process.

.BOBHFNFOU PG BCOPSNBM BQQFBSBODF JO JOGMVFO[B WBDDJOF

7R HQVXUH WKH TXDOLW\ RI WKH LQÀXHQ]D YDFFLQH 7DLZDQ V PDQDJHPHQW VWUDWHJ\ LV LQ OLQH ZLWK WKH
:RUOG +HDOWK 2UJDQL]DWLRQ :+2 2Q WKH EDVLV RI $UWLFOH RI WKH Pharmaceutical Affairs Act"

and the "Regulations of the Lot Release Procedures for Biologics, HDFK EDWFK RI LQÀXHQ]D YDFFLQH
is required to provide relevant information for review and TFDA staffs will be sent to inspect the
vaccine's condition of transportation, storage, and random sampling before the vaccine entering
the market. According to the Chinese Pharmacopoeia, a total of 11 tests were conducted, including
DSSHDUDQFH LGHQWL¿FDWLRQ S+ YDOXH IRUPDOGHK\GH WRWDO SURWHLQV VWHULOLW\ WHVW EDFWHULDO HQGRWR[LQ
abnormal toxicity test, ovalbumin, virus inactivation and potency test, to ensure the efficacy and
VDIHW\ RI WKH YDFFLQH 7KH &HUWL¿FDWH RI ORW UHOHDVH ZLOO EH LVVXHG RQO\ LI WKH YDFFLQH SDVVHV WKH

LQVSHFWLRQ SURFHVV $ 3KDUPDFHXWLFDO ,QVSHFWLRQ &HUWL¿FDWH ZLOO EH ODEHOHG RQ WKH SDFNDJH RI WKH
product for sales and use for the general public.

On October 26 and 29, 2018, TFDA received 2 reports issued about vaccines with abnormalities
in color and white substance respectively. TFDA instantly carried out the external inspection at the
UDWH RI RI WKH ORW UHOHDVH YROXPH DW ORZ WHPSHUDWXUH VWRUDJH 0RUHRYHU 7)'$ VHQG LQVSHFWRUV
WR FDUU\ RXW WKH H[WHUQDO LQVSHFWLRQ DW WKH UDWH RI RI WKH ORW UHOHDVH YROXPH EHIRUH WKH ORW UHOHDVH
procedures (Figure 3-11).

'5*3 'PVSJFS
'JHVSF cc-JRVJE DISPNBUPHSBQIZ UBOEFN NBTT TQFDUSPNFUFS 'JHVSF cc
USBOTGPSN JOGSBSFE
TQFDUSPTDPQZ

59