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Food and Drug Administration


2. Medicinal Product Safety and Quality Improvement Project

(1) To improve medicinal product safety and quality, research results were referenced to formulate 20

clauses related to pharmaceutical affairs such as contents of package inserts of medicinal products,

drafts for the amendments of the

Pharmaceutical Affairs Act and the Regulations for registration of

Medicinal Products

, drafts for

in vitro

diagnostic device (IVD) package inserts and clinical evaluation

review standards, and inspection standards for biomedical products. A total of 45 medicinal product

safety re-evaluations have also been carried out in response to key global medicinal product safety


(2) Emerging technologies have also been employed to research, develop, and establish testing methods

for medicated cosmetics. A total of 15 research reports on test techniques have been completed

accordingly. Additionally, 10 recommended testing methods for cosmetics were developed and

publicized on TFDA website to provide a basis for testing methods for marketed cosmetics as well as

a reference for vendors and labs.

(3) Active monitoring of medicinal product safety is also used for early detection of medicinal product

safety signals to clarify the correlation between risks and drugs, improve risk-benefit ratios for

medicinal products, reduce improper use, and prevent the incidence of adverse reactions.

3. Quality and Safety Risk Management System that Integrates Traditional Chinese

Medicine and Pharmaceutical Products

(1) Phase 1 Traditional Chinese Medicine (TCM) and pharmaceutical product ADR reporting systems have

been integrated to establish a single reporting channel that improves the ease of reporting incidents by

both medical personnel and the general public while also improving management efficiency of cases


(2) In response to PIC/S and relevant laws as well as international harmonization, two regulatory science

recommendation reports for generic drugs were completed (on pharmacokinetics/pharmacodynamics

and chemical manufacturing and controls) to serve as a basis for future regulatory revisions or consultation

and improve market release efficiency of the products.

(3) The drug permit license system has been employed to filter through the 23,608 permits on the

system, generate a list of missing medicinal products, formulate the

Medicinal Product Deficiency

Allocations and Comprehensive Treatment System Project

for reducing the incidence of medication

gaps to make sure medication accessible for the patients' rights.