Page 54 - 2021 Taiwan Food and Drug Administration Annual Report
P. 54
WHH RI WKH 0LQLVWU\ RI +HDOWK DQG :HOIDUH´ 'UXJV 7)'$ KHUHLQDIWHU UHIHUUHG WR DV
convened the 41st and 42nd meeting in 2020 the Pharmaceutical Plant) for controlled
and added a total of 8 items for new con- drugs was completed in July 2017 in order
trolled drugs and active pharmaceutical in- to improve product quality and expand
gredients. The Agency and the local health production capacity. The Pharmaceutical
bureaus implemented the controlled drug Plant passed the PIC/S GMP compliance
audit project plan. A total of 230 compa- assessment at the end of 2018. After the
nies were checked and 43 violations were UHVXPSWLRQ RI SURGXFWLRQ LQ D QXPEHU
IRXQG ZLWK D YLRODWLRQ UDWH RI of research and development projects were
,, ,Q UHVSRQVH WR WKH &29,' SDQGHPLF launched in 2020. The plan was to return
on-site education and training courses have the contract manufacturing and imported
EHHQ UHSODFHG E\ RQOLQH FRXUVHV DQG ZLWK SURGXFWV WR PDQXIDFWXULQJ LQ KRXVH DQG
WKH IRXU FRXUVHV ³6XPPDU\ RI &RQWUROOHG to start the construction of the plant to
'UXJV 0DQDJHPHQW 5HJXODWLRQV´ ³0DQ- achieve the goals of manufacturing drugs
agement Regulations and Precautions for GRPHVWLFDOO\ DQG KDYLQJ VX൶FLHQW VXSSO\
Applications for the Use of Controlled
Drugs in Medical Education Research Pro- Implementation Strategy
JUDPV´ ³.H\ 3RLQWV RI &RQWUROOHG 'UXJV
Audit and Introduction to Violations; and Newly-constructed plants will add
6OHHS 'LVRUGHUV DQG 8VH RI 6OHHSLQJ 3LOO´ SURGXFWLRQ OLQHV IRU QHZ GRVDJH IRUPV DQG
have been made available online at the the goal is to establish production lines for
“e-Public Service Academy + Learning RUDO OLTXLGV FDSVXOHV DQG SDWFKHV \HDU E\
3ODWIRUP ´ year. The plant is remodeled to expand the
storage space and make the production space
Section 2 more complete. The developed products
SULRULWL]H LQMHFWLRQV DQG RUDO OLTXLGV
Improved the IROORZHG E\ WKH FDSVXOH GRVDJH IRUP DQG
Pharmaceutical Quality then the patch type with a higher technicality
of Schedule 1 and 2 level.
Controlled Drugs
$FKLHYHPHQWV DQG %HQH¿WV
Introduction of the Policy
The Pharmaceutical Plant has prioritized
The newly constructed plant of The the mass production of 2 mL of fentanyl
Pharmaceutical Plant of Controlled injection in-house and the trial production of
Alfentanyl injection in 2019. The injection
52
