Page 110 - 2021 Taiwan Food and Drug Administration Annual Report

Date of Name Important content
announcement
Announced the “Streamling Streamline the review process of clinical trials to improve the
July 1 measures for clinical trials of FRPSHWLWLYHQHVV DQG HႈFLHQF\ RI WKH GRPHVWLF FOLQLFDO WULDOV
medicinal products”

Established the “Standards

July 21 of Review Fees for the Charges for various cases of western medicines registration.
Registration of Western

Medicines”

July 22 Established the “Basic Real-world evidence is the latest international clinical
Considerations in Supporting application trend. TFDA has taken into consideration the
Drug Research and latest international management practices and established
Development with Real-World the “Basic Considerations in Supporting Drug Research
Evidence” guidance” and Development with Real-World Evidence” as reference
for domestic drug R&D.

July 23 Amended the Wei-Shu-
Y a o - Z h i # 0 9 0 0 0 1 8 0 4 3 Refer to the international SUPAC-MR to revise the
a n n o u n c e m e n t “ P o s t - relevant attachments and tables to ensure that the
m a r k e t c h a n g e s o f o r a l major and minor changes do not affect the quality of
solid preparations”, dated pharmaceutical preparations. Basis of amendment:
March 19, 2001, from the Article 46 of the “Regulations for Registration of Medicinal
Department of Health of the Products”.
Executive Yuan

August 25 Renamed the “Application
form for adverse drug
reaction reporting database” Title was revised as the “Application form for adverse
to “Application form for reactions to western medicines and medical devices
adverse reactions to western reporting database”.
medicines and medical
devices reporting database”

Adding “Burosumab” (solution for injection, 10, 20, 30 mg/

August 26 Updating the list of drugs mL), “Siponimod fumaric acid” (film coated tablet, 0.25,
for The Rare Disease and
Orphan Drug Act 2 mg), “KH2PO4 + Na2HPO4 + NaH2PO4·H2O” (tablet,
KH2PO4 155 mg + Na2HPO4 852 mg + NaH2PO4·H2O 130
mg), and revised “Nusinersen” (injection, 2.4 mg/mL)

indications.

August 28 Promulgating “The
Review Considerations for
Registration of Over-the- For those drugs are over-the-counter and have been sold
Counter Drugs that Have in A10 countries for 10 years or longer but are regarded as
Been Sold in A10 Countries drugs of new therapeutic compounds, new dosage forms,
for 10 Years or Longer But Are new administration doses, or new unit strength in Taiwan, we
Regarded as Drugs of New made a specific registration process that require less clinical,
Therapeutic Compounds, pharmacokinetic, and pharmacological/toxicological data since
New Dosage Forms, New the drugs mentioned above pose a lower risk.
Administration Doses, or New
Unit Strength in Taiwan.”

Amended some provisions
of the “Regulations for Good Amended some provisions of the “Regulations for Good
Clinical Trials of Drugs”, and Clinical Trials of Drugs”, and renamed it to “Regulations
renamed it to “Regulations for for Good Clinical Practice”.
Good Clinical Practice”

September 3 Amending the list of drugs “Midicinal nitrous oxide” was included in the items to be
traced and tracked for declaration, which was formally
catagorized for tracing the implemented on October 1, 2020 to strengthen distribution
VRXUFHV DQG WUDFNLQJ WKH ÀRZ monitoring and prevent it from being misused.
prescribed in Article 6-1 of the
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