Page 39 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

(5) Monitoring of Virility Drugs on the Market
Illegal addition of pharmaceutical additives to virility products were monitored in 2015. A total
of 101 samples were taken and tested, and no virility ingredients had been found. However, two
products were found to contain caffeine that was not indicated on the label. All these cases were
transferred to local health bureaus for subsequent handling.
(6) Enhancing the Medicinal Product Quality Monitoring Information System
The enhanced Medicinal Product Quality Surveillance Mangement Information System formally
came online in January 2015. In addition to improving the convenience of the reporting process,
quality information of medicinal product from the product life cycle was also integrated in this
system in order to improve handling ef?ciency of quality incidents. Part II - Key Administrative Results Medicinal Products Management
(7) Promulgation of the Regulations for Medicament Recall
There is a need to enhance medicinal product recall procedures, increase medicinal product
license holde's liabilities, and prevent medicinal products with suspect quality from being used
by consumers. To establish these regulations, TFDA referred to provisions stipulated in Article
80 Paragraph 3 of the Pharmaceutical Affairs Act to promulgate the Regulations for Medicament
Recall, and suspended the corresponding Directions on Implementation of Recall Action of
Pharmaceuticalson August 5, 2015.
2. Good Distribution Practices (GDP) Management of Medicinal Products
(1) Medicinal product quality requirements of various health authorities around the world have
expanded from the production-oriented GMP to the transport-oriented GDP in order to maintain
and safeguard product quality during storage, transportation, and delivery processes.

(2) To ensure the comprehensiveness of the medicinal product quality management system
across the entire supply chain, TFDA started gradual establishment of a medicinal product
distribution management system in Taiwan since 2011. From 2012 to the end of 2015, TFDA
carried out consultation visits with 145 businesses and 290 sites that include pharmaceutical
manufacturers, agents, and logistics businesses, of which 107 businesses were given excellent
ratings for supporting the medicinal product GDP consultation visits. During the period, TFDA
also held training courses to improve quality management concepts for medicinal products
amongst transportation and sales businesses.
(3) TFDA released the GMP for Modern Pharmaceutical Products (Part 3): Distribution on July
16, 2015 that includes details, items, and schedule for implementing these standards. All
manufacturers and dealers holding permits for modern pharmaceutical products must
comply with the provisions of the GMP standards by January 1, 2019 to successfully build a
comprehensive management system for the pharmaceutical supply chain.
3. Prohibition of Illegal Drugs, Food Products, and Cosmetics
The MOHW assembled the Joint Task Force for the Prohibition of Counterfeit and Inferior
Drugs on April 30, 2014, working jointly with various government ministries and agencies
such as the Ministry of Justice, National Police Agency, Coast Guard Administration,
Customs Administration, and National Communications Commission to strengthen measures
for identifying and intercepting illegal drugs and monitor illegal food, drugs, and cosmetic
advertisements. Results of activities implemented by the Joint Task Force are listed in the
following:

(1) Continued to monitor illegal food, drugs, and cosmetics in the market. In 2015, a total of 659
illegal drugs were identified, of which administrative actions were initiated against 122 cases,
with total fines amounting to NT$ 4.324 million. The rate of identifying and intercepting illegal
products dropped from 27.22% in 2010 to 2.34% in 2015 as shown in Figure 2-2-4. 37