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4
Embarking on a New Era of Food and Drug Management
On January 1, 2010, The Department of Health of the Executive Yuan integrated the Bureau of
Food Safety, the Bureau of Food and Drug Analysis, the Bureau of Pharmaceutical Affairs, and
the Bureau of Controlled Drugs and formed the Taiwan Food and Drug Administration (TFDA).
This was done in order to effectively integrate resources and promote administrative efficiency,
so as to unify the management of food and drug safety. On July 23, 2013, in response to the
reorganization of the central government, the Food and Drug Administration went through a
status change to be affiliated under the Ministry of Health and Welfare. TFDA is committed to
building a strong management system in order to achieve food and drug safety for the general
public.
Stating our administrative activities and outcomes in the 2013 annual report, we have introduced
the TFDA organization infrastructure and administration objectives related legislation and policy
promotion for food, drugs and control drugs, medical devices and cosmetics. Six supporting
systems are included to form a web-like network. Achievements in product quality assurance,
factory operation and management, distribution, monitoring and border management are
presented. Major events of the year, chronicles and statistics in 2013 are also listed for
reference.
Management Innovation and Quality Service
On June 19, 2013, the
“
Act Governing Food Sanitation
”
was amended to fortify food safety
management. Industry is being held responsible for more self-management. Also a product
Food traceability system was established, as well as increased penal provisions. By the end
of 2013, the TFDA had listed the permitted usage and limits for a total of 800 food additives.
Since 2011, the TFDA had encouraged the food additive related companies to voluntarily
register in the TFDA online information system. By the end of 2013, there were 669 companies
registered with information on 27,712 food additive items, thus completing the food additives
registry information system. Border inspection and post-market monitoring assisted in forming a
comprehensive food safety control system. The TFDA continues to develop innovative analytical
technology for the detection of hazardous substances in food, while the function is also useful
for food related emergencies. The maleic anhydride testing method was developed and used
in the modified starch incident in 2013.This is a leading discovery preceding the US, Europe
and Japan. The TFDA also leads in developing a new high resolution liquid chromatography
tandem mass spectrometry method to analyze copper chlorophyll in oil. This innovation was
developed to meet the urgent demands for the adulterated olive oil incident in 2013. By the end
of 2013, there were a total of 151 laboratories that have passed the requirements and received
accreditation for testing a total of 1,192 items.
In order to safeguard national medication safety, an overhaul of the drug review mechanism
has been performed. Taking for example the new drugs that went through the
“
priority review
mechanism
”
, the approval time frame has been shortened more than 33% in 2013, ahead of
the USA, Europe and Japan. In 2013, a new lung cancer target therapy medication, Afatnib,
received approval from the TFDA ahead of other countries. In order to provide onsite counsels
to industry, in September, 2013 we set up two TFDA medical equipment legal consulting offices,
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