Page 55 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report Chapter 4. Distribution and Post-market Management

3. Facilitate medicinal products GDP system

(1) PIC/S has promulgated GDP in 2014 and extended its requirements on medicinal
products quality control from GMP to GDP. The main purpose was to prevent the
storage, transportation and distribution process of medicinal products from affecting
product quality.
(2) TFDA promotes medicinal products distribution management system since 2011
and opens for applying medicinal products GDP counseling visits. By the end of
2016, 590 pharmaceutical factories, distributors and logistics were inspected, and

107 companies with excellent performance, will continue receiving counseling
inspections and training programs.
(3) On February 18, 2016, promulgate the implementation details and schedules for
“Good Manufacturing Practice (GMP): Distribution”. Manufacturers and dealers
with medicinal product permit licenses must comply with such standards completely
by 2019.

4. Distribution management for controlled drugs

(1) TFDA has established “Controlled drugs management information system”.
Institutions or business with controlled drug registration licenses are required to
record daily increase and decrease of stocks and inventory of controlled drugs
truthfully and report the records regularly. The distribution is managed through
auditions and inspections on upstream and downstream sources.
(2) To reinforce the management of controlled drugs, a total of 17,145 on-site inspections
were conducted in 2016. There were 437 institutions been violating the regulations
and the violation rate was 2.55% (Table 7 in Annex II for inspection statistics). A

total of 351 institutions with higher consumption rate or increased consumption rate
of hypnotics were inspected in projects of 2014. Of which, 59 were found violating
and the violation rate was 16.81%.
(3) The top two violations are “incomplete documentation of controlled drug handbook”
and “incomplete/ missing routine recording of inventory”. Violators all received
relevant penalties.

53