Page 41 - 2021 Taiwan Food and Drug Administration Annual Report
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announcement of the amendment of the the legislative intent of the patent law to
“Guidance on Investigational Gene Therapy SURWHFW SDWHQWHHV DIILUP WKH UHVHDUFK DQG
Products” has been announced on November GHYHORSPHQW HIIRUWV RI QHZ GUXJ OLFHQVHHV
2. On June 30 and August 25 of the same and provide generic drug companies with
\HDU WKH “Guidance on management transparent patent information to learn
of traceability of cell and gene therapy of the drug patent status in advance and
products” (Draft) DQG WKH “Guidance on clarify related infringement concerns before
donor informed consent of cell and gene going on the market. The launched generic
therapy products” (Draft) were announced drugs then will not be subject to the risk
respectively. Both guidances mentioned of suspension of sales at any time due to
above continue to improve the regulatory LQIULQJHPHQW LVVXHV ZKLFK FDQ DIIHFW WKH
environment for regenerative medicinal rights and interests of patients. As of the end
products. RI WKHUH ZHUH FDVHV RI GUXJ SDWHQW
linkage challenging design around.
II. Facilitation on New Drug Ap-
provals Section 2
:LWK WKH FRUH REMHFWLYHV RI TXDOLW\ Reinforced the Drug
F R Q V L V W H Q F \ F O D U L W \ H II L F L H Q F \ D Q G Risk Control and Digital
WUDQVSDUHQF\ LQ UHYLHZ RI GUXJV DQG ZLWK Management
the expectation to reach early access of
QHZ GUXJV 7)'$ UHLQIRUFHV WKH WZR ZD\ Introduction of the Policy
communication between the regulators
DQG LQGXVWULHV SURPRWLQJ UHJXODWRU\ Many countries have successively de-
KDUPRQL]DWLRQ LPSURYLQJ GUXJ UHYLHZ YHORSHG HOHFWURQLF VXEPLVVLRQ VSHFL¿FDWLRQV
and management system. Among the 121 for drug registration and a cross-platform
QHZ GUXJV DSSURYHG LQ DUH QHZ electronic drug information exchange model
drugs with new main ingredients and 35 WKDW LV FRPSDWLEOH DQG VWUXFWXUHG ZLWK WKH
are biological medicines. The number of advancement of international pharmaceu-
QHZ GUXJV DSSOLFDWLRQV FORVHG FDVHV DQG tical regulations and electronic drug policy
the review time in the past few years are as management. In order to strengthen the
shown in Figure 3-1. PDQDJHPHQW RI WKH GUXJ VXSSO\ FKDLQ 7)'$
has established the trace and track system of
III. Implementation of the patent drugs in accordance with Article 6-1 of the
linkage system of drugs “Pharmaceutical Affairs Act” to deter the
The patent linkage system can achieve
39
