Page 111 - 2021 Taiwan Food and Drug Administration Annual Report

Date of Name Important content
announcement

The guidelines were formulated based on the E6 (R2) of

September Formulated the “Guidelines the International Council for Harmonisation of Technical
22 for Good Clinical Practice” Requirements for Pharmaceuticals for Human Use (ICH) as a
supplement to the Regulations for Good Clinical Practice, and

reference for the personnel of handling clinical trials.

September Updating the list of drugs Added and recognized “Givosiran” (injection, 189 mg/mL),
29
for The Rare Disease and “Chenodeoxycholic acid” (capsule, 250 mg), and “Edaravone”

Orphan Drug Act (injection, 1.5 mg/mL).

November 2 Established the “Guidance on These criteria were established for the review of the
Investigational Gene Therapy manufacturing process control, non-clinical trials, and clinical
Products” trials based on the characteristics of gene therapy products in
order to promote the domestic development of gene therapy.

1. Amended in accordance with international guidelines to

enable doctors to prescribe addictive narcotic drugs after

HYDOXDWLQJ EHQH¿WV DQG ULVNV WR UHOLHYH WKH V\PSWRPV RI

dyspnea in terminal patients.

November 11 Amended the “Precautions 2. Amended the number of days for which doctors can prescribe
for the management of home addictive narcotic drugs for oral or topical use. In the future,
use addictive narcotic drugs those in rural areas who use addictive narcotic drugs at
by terminal patients” home and need to extend their prescriptions can seek
medical treatment at the nearest medical institution instead of

visiting the hospitals with a “Controlled Drugs Management

(Committee)” to increase the accessibility of home-use

addictive narcotic drugs for terminal patients living in remote

rural areas.

November Formulated the “Regulations The Regulations were established to maintain the security
12 for the Security and the and accuracy of personal data, and to establish practices
Maintenance of Personal for the management, audit, preservation and improvement
Information Files in of personal data in accordance with the authorization of
Wholesaling and Retailing the Personal Data Protection Act.
Western Pharmaceuticals”

We specifically demonstrated the guidance for using

Formulated the “Guidance on the standardized electronic formats when applying

November Taiwan Electronic Common for drug registration and ensuring to compliance with
19
Technical Document (eCTD) the requirements of the electronic common technical

Validation Criteria” document Requirements from International Council for

Harmonization for Pharmaceuticals for Human Use (ICH).

Adding “Risdiplam” (powder for oral solution, 0.75 mg/mL),

Updating the list of drugs “Ofatumumab” (solution for injection, 50 mg/mL), “Ravulizumab”

December 25 for The Rare Disease and (concentrate for solution for infusion, 10 mg/mL), “Human C1-

Orphan Drug Act esterase inhibitor” (injection, 500 IU), “Ataluren” (granules for

oral suspension, 125, 250, 1000 mg).

December 30 Formulated the chart of The chart of review process and time management was
“Review process and established to make the registration of orphan drugs more
time management for the transparent and enable applicants to understand the timing
registration of orphan drugs” of each phase, further ensuring the efficiency, consistency,
transparency and predictability of review.

Formulated the “Guidance on These Guidelines were formulated to enable applicants to
December 31 Taiwan Electronic Common meet the requirements of the ICH eCTD Electronic Common

Technical Document (eCTD)” 7HFKQLFDO 'RFXPHQW 6SHFL¿FDWLRQ 9

109