Page 54 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

announcements were released for canned food products, special nutrient foods,

dairy products, and food additive industries. Ten manufacturing businesses
involving capital more than NT$30 million dollars, including edible oil, sugar,
salt, flour, starch and soy sauce industries, are also required for certification. By
the end of 2016, 519 certification audits were carried out.
C. The third tier quality control: Audition capacities
(A) Auditing projects: Auditing projects summarzie local government, health
bureaus audition and monitoring data, evaluate domestic and overseas food
safety alert and forums, give a comprehensive interpretation and supervision
over focused administrative projects, high-violator, high-risk, high-profile

projects, and conduct project audition sampling jointly with local government
and health bureaus. In 2016, 47 project were conducted.
(B) Inspection program of the Executive Yuan Joint Task Force for Food
Safety: For essential food categories that have significant impacts on fellow
citizens, TFDA worked with relevant departments and agencies of the
central government, local governments, inspectors, and police forces to
leverage their respective potentials when implementing key inspection. Three

important joint audits were completed in 2016.
(C) Supervising food inspection responsibilities of local governments, health
bureaus, and departments: In 2016, a total of 112,382 Good Hygienic Practice
(GHP) audits for food products, 424,402 product labeling inspection, and
49,800 product sampling tests were carried out. Refer to Table 6 in Annex II
for detailed local health bureaus food audition statistics.

2. Medicinal product trace and track

To effectively control medicinal products sources and distribution, Pharmaceutical
Affairs Act added Article 6.1 on December 2, 2015 and authorized the establishment
of “ Regulations governing the trace and track system for medicinal products” based
on Pharmaceutical Affairs Act added Article 6.1, paragraph 3 on September 6, 2016.
The regulations clearly specify that medicinal product categories announced by the
central health competent authorities, the license holders or distributors shall establish

information system for tracing the source and tracking the flow of medicinal product.
TFDA primarily plans to include three categories of medicinal products including
plasma-derived preparations, vaccines and botulinum toxin into stage 1 advanced
traceability scope.

52