Page 73 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

sampling results failed to meet the speci?cations, where factory inspection identi?ed quality issues,
or where pharmatheutical companies have initiated product recalls voluntarily, and where the drugs
have been withdrawal because of safety issue. In 2015, a total of 303 medicinal products were
recalled due to quality problem.

c. Drug Safety and Quality Monitoring
(a) Establishing the Proactive Drug Safety Monitoring Mechanism
The Proactive Drug Safety Monitoring Mechanism was sequentially established since 2010 by
realizing the safety profile of medicinal products with important potential risks in Taiwan using
National Health Insurance Database in order to provide a reference for drug safety re-evaluations Part II - Key Administrative Results Risk Assessment and Management
and determining risk management measures. Overall safety analysis projects were carried out for 10
medicinal products in 2015.
(b) Enhancing the Medicinal Product Quality Monitoring Information System
The enhanced Medicinal Product Quality Surveillance Mangement Information System was
established from 2013 to 2014. The Informatin System has improved the convenience of reporting
drug product defects or therapeutic inequivalence and enhanced the management of reported
cases, drug recalls and global drug quality alerts.The medicinal product quality information from the
product life cycle was also gradually integrated in this system in order to improve handling ef?ciency
of medicinal product quality incidents. The Information System formally came online in January 2015.

(c) Implementing Risk Management Plans for Medicinal Products in Pharmaceutical Companies
Since 2010, the system of Medicinal Product Risk Management Plans for Pharmaceutical Companies
was gradually established for medicinal products with specific risk concerns.Pharmaceutical
companies and medical institutions are required to work together in order to implement various
risk control tools such as patient drug usage instructions, medical staff notification, and special
preventive measures. Follow-up assessments of implementation effectiveness are also carried out
regularly to ensure the public's drug use safety. Risk management plans are required for diabetic
medication that include rosiglitazone, anti-epileptic drugs that contain carbamazepine, TNF-alpha
blockers and acne medication with cyproterone acetate and ethinyloestradiol.

(3) Training of Risk Assessment Professionals
In 2015, TFDA held a total of 12 seminars advocating the reporting of ADRs and defective products
for health professionals, health bureaus and departments, pharmaceutical companies, and members
of the public. TFDA also worked with the Taiwan Pharmacy Forum to provide free online courses
over a 2.5-month period in order to promote reporting of ADRs. TFDA also held six training courses
for pharmaceutical company personnel responsible for drug safety monitoring in order to help the
companies establish safety monitoring and risk management systems.

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