Page 114 - 2020Taiwan Food and Drug Administration Annual Report

Table 5c Addendum/amendment to the regulations and standards related to
pharmaceutical administration in 2019

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Updating the list of drugs for Adding “Patisiran (Solution for infusion, 2mg/mL)” and
+BOVBSZ The Rare Disease and Orphan “Icatibant (Injection, 10mg/mL).”
Drug Act
Revised part of the articles of Amended the some of the clauses in the “Regulations for
“Regulations for Registration of Registration of Medicinal Products” in order to keep up with
Medicinal Products” the trend of international drug management, in line with
'FCSVBSZ online E-submission, simplify the review process, enhance
international competitiveness and enable consumers to easily
see the labeling of the manufacturing date and shelf life.
Stipulated the “Regulations for On the basis of paragraph 2, Article 48-19 in the
WKH 1RWL¿FDWLRQ RI 'UXJ 3DWHQW Pharmaceutical Affairs Act, we stipulated the “Regulations for
Linkage Agreements” WKH 1RWL¿FDWLRQ RI 'UXJ 3DWHQW /LQNDJH $JUHHPHQWV” in order
.BSDI to prevent unfair agreements or agreements with restrictive
competition that hinder other generic drugs to be on the
market and improperly affect patient’s access of medicine,
public health and transaction order on the market.
Announcement of the The “Guidelines for Good Preparation Operations of Positron
stipulation of “Guidelines for Emission Tomography” was announced to effectively
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of Positron Emission PHGLFDO LQVWLWXWLRQV DQG HQVXUH WKH VDIHW\ RI WKH SHRSOH V XVH
Tomography” of the medicine.
Amendment to Article 4 of the In line with the government to facilitate the development of
“Regulations on Management biomedical industry and enhance Taiwan’s competitiveness
of Medicament Samples and in clinical trials in the world, we manage the materials and
Gifts” HTXLSPHQW UHTXLUHG IRU FOLQLFDO WULDOV EDVHG RQ WKH OHYHO RI
risk; For the low-risk of consumable sample collecting sets
in clinical trials are simplified their application procedures ,
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In line with the residency policy of the Ministry of the Interior,
the Alien Resident Certificate (ARC) and Alien Permanent
Resident Certificate (APRC) are deemed as an identity
document with the same effect as a passport. Therefore,
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IRUHLJQHUV WR DSSO\ WR LPSRUW VHOI XVH GUXJV ZHUH UHOD[HG
Announcement of the The business undertakings of western pharmaceutical
“Implementation Details and SUHSDUDWLRQV WKDW UHTXLUH FROG FKDLQ VWRUDJH DQG
Transition Periods of the WUDQVSRUWDWLRQ IRU ZKROHVDOLQJ LPSRUWLQJ DQG H[SRUWLQJ
.BZ Western Pharmaceuticals processes should apply to TFDA for inspection of the
Good Distribution Practice “Western Pharmaceuticals Good Distribution Practice
(GDP) Regulations for Regulations,” DQG WKH\ VKDOO IXOILOO WKH UHTXLUHPHQWV RI WKH
Pharmacy Operators regulations before December 31, 2021.
Reassessed the risk factors of :KHQ WKH GUXJ SURGXFWV FRQWDLQLQJ EHQ]RFDLQH DUH XVHG LQ
medicinal products containing children, it may occasionally cause rare but potentially fatal
%HQ]RFDLQH XVHG LQ FKLOGUHQ blood disorder, “methemoglobinemia.” Therefore, TFDA
re-assess the risk factors of these drugs used in children
according to Article 48 of the Pharmaceutical Affairs Act.
.BZ Abolished the “Announcement 7KH SULQFLSOH IRU WKH XVH RI GUXJV FRQWDLQLQJ EHQ]RFDLQH
RI 5HTXLUHG 5HPDUNV LQ was announced and hence the former Shu-Shou-Shi-Zi No.
Package Insert for Drugs 1011406106 “$QQRXQFHPHQW RI UHTXLUHG UHPDUNV LQ SDFNDJH
&RQWDLQLQJ %HQ]RFDLQH” LQVHUW IRU GUXJV FRQWDLQLQJ EHQ]RFDLQH” announced by the
'HSDUWPHQW RI +HDOWK ([HFXWLYH <XDQ RQ 6HSWHPEHU
2012 was abolished.
Updating the list of drugs in Adding “Migalastat(capsule, 123mg),” indication for the
The Rare Disease and Orphan treatment of Ú16 year-old patients with a confirmed
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112 Drug Act diagnosis of Fabry disease and an amenable galactosidase
alpha gene (GLA) variant based on in vitro assay data.