Page 33 - 2019食藥署年報(英文版)
P. 33

OE
                        $FSUJGJDBUJPO GPS     UJFS RVBMJUZ DPOUSPM  BOE  GPPE FYQBOTJPO
                        WFSJGJDBUJPO QSPHSBN

                         Taiwan’s health supplements industry is booming. In addition to selling domestically, it
                     LV H[SRUWHG WR PDQ\ FRXQWULHV  +RZHYHU  VLQFH WKH H[LW RI 7DLZDQ¶V *03 FHUWL¿FDWLRQ V\VWHP
                     LQ       0DOD\VLD KDV UHTXHVWHG RI¿FLDO *03 FHUWL¿FDWLRQ GRFXPHQWV EHIRUH H[SRUWLQJ KHDOWK
                     supplements to the country. Therefore, TFDA has negotiated with the Malaysia government
                     VHYHUDO WLPHV WR SURYLGH WKH VXEVWLWXWLRQV IRU WKH EXVLQHVV  ZKLFK ZLWK WKH FHUWL¿FDWLRQV RI WKH
                      nd
                     2  WLHU TXDOLW\ FRQWURO DQG WKH IRRG H[SDQVLRQ YHUL¿FDWLRQ SURJUDP  WKH EXVLQHVVHV ZLOO UHFHLYH
                     the approval letter that meets the "Guidelines on Good Manufacturing Practice for Traditional
                     Medicines and Health Supplements" in Malaysia, and then the application of inspection may be

                     submitted to National Pharmaceutical Regulatory Agency (NPRA), Malaysia.

                        4UVEZ BOE BOBMZ[F UIF (PPE .BOVGBDUVSJOH 1SBDUJDF 3FHVMBUJPOT PG

                        IFBMUI TVQQMFNFOUT

                         Considering the export demand is not limited to Malaysia, and in response to the
                     characteristics and needs of Taiwan’s health supplements industry, in 2018, after comparing the
                     GMP regulations of health supplements manufacturers in the United States, Japan, Malaysia and
                     ASEAN, we studied and analyzed our GMP regulations of health supplements, and will continue
                     to recommend relevant inspection standards, verifying management system and operating
                     procedures in the future, as well as promoting health supplements manufacturers in the nation

                     can establish standards in line with GMP to ensure the quality and enhance the international
                     competitiveness of the industry.


                     0VUDPNFT BOE #FOFGJUTVUDPNFT BOE #FOFGJUT
                     0
                        4JNQMJGZ UIF BQQMJDBUJPO QSPDFTT


                         7KHUH ZHUH     EXVLQHVV RSHUDWRUV WKDW VKRXOG EH FHUWL¿HG LQ       DQG DERXW     RI WKHVH
                                                                                                  nd
                     DSSOLFDWLRQV VXFFHVVIXOO\ REWDLQHG WKH FHUWL¿FDWLRQV  :LWK WKH WKLUG SDUW\ FHUWL¿FDWLRQ RI    tier
                     TXDOLW\ FRQWURO  VLPSOL¿HG WKH DSSOLFDWLRQ SURFHVV IRU IRRG H[SRUW DQG UHGXFHG ZDLWLQJ WLPH DQG
                     cost of business operators.

                        *NQSPWF QSPEVDU RVBMJUZ BOE QSPNPUF FYQPSU

                         %\ WKH HQG RI       WKHUH KDG EHHQ   EXVLQHVV RSHUDWRUV SDVVHG WKH WKLUG SDUW\ FHUWL¿FDWLRQ
                        nd
                     of 2  tier quality control and "food expansion verification program" qualification practices,
                     received the approval letter from TFDA and submitted the application of inspection to Malaysia.

                     Related products were successfully exported to Malaysia and there are more business operators
                     DSSO\LQJ IRU WKH FHUWL¿FDWLRQ FRQWLQXRXVO\
                                                                                                           31
   28   29   30   31   32   33   34   35   36   37   38