Page 7 - Taiwan Food and Drug Administration 2016 Annual Report

For the improvement of life cycle management for drugs and pharmaceuticals, a historical
record of 170 new drugs have been approved in 2015, where two of these drugs were domestically
produced novel immune and antibody drugs for cancer therapy, ensuring that the drugs are available
for patient treatment as early as possible. In 2015, comprehensive implementation of PIC/S GMP was
enforced for local drug companies and pharmaceutical manufacturers that export drugs to Taiwan
in order to better align drug manufacturing quality with international standards. To lay down a robust
pharmaceutical supply chain management with excellent quality, TFDA also provided consultation
to businesses to support compliance with Good Distribution Practice (GDP) for pharmaceuticals.
TFDA also listed propofol (colloquially referred to as milk of amnesia) as a controlled drug in order to
reduce potential abuse.
To provide a standard reference for medical device companies during product development as
well as product registration and inspections, and to promote the development of this industrial sector,
TFDA promulgated the Reference Guidance for Medical Software Categorization and Classi?cation.
In 2015, mail order purchases and sales of Class II medical devices and items were legalized for the
general public, providing people with greater convenience and options when purchasing medical
devices. The voluntary Good Manufacturing Practice (GMP) for cosmetics was also promoted to
enhance product source management.
TFDA actively formulated inspection methods, improved inspection technologies, and quickly
released clear testing methods for sea cucumbers soaked in glacial acetic acid and dyed durian.
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Addendum to the 7 Version of the Chinese Pharmacopoeia was also published to provide a
standard reference for testing purposes. TFDA also strategically employed civilian-owned resources
and testing capacities of local health bureaus and departments to achieve specialization of testing
work. As of the end of 2015, a total of 163 labs have been accredited, allowing them to perform tests
in response to emergencies.
Joint Partnership, International Collaboration, and Consumer Protection
To enhance international visibility, promote bilateral activities, and expand Taiwan's global
market, TFDA played active roles in global harmonization organizations, signed a Joint Declaration
for Drugs and Medical Devices with Germany, and organized the Third Joint Conference of Taiwan
and Japan on Medical Products Regulation. Pursuant to the Cross-Strait Food Safety Agreement
and Cross-Strait Cooperation Agreement on Medicine and Public Health Affairs, TFDA established
noti?cation and exchange systems required under these agreements to promote collaboration and
joint developments in the pharmaceuticals and health sectors.
To achieve consumer protection and risk communication, TFDA maintains a Busting Myths about
Food and Drugs on its website, where expert opinions and scienti?c experiments are employed to
dispel misunderstandings and resolve public concerns. Also, in order to expand food safety networks
and communicate accurate information, TFDA also set up the first multiple-departmental 1919
National Food Safety Helpline that offers an integrated telephony service for food incidents related to
whistle-blowing, inquiries, consumer concerns, fresh produce, and questions from small and medium
enterprises (SMEs).
Working Around the Clock to Establish a Homeland with Safe Food and
Pharmaceuticals
TFDA has taken up the mission of ensuring the quality and safety of food and medical products
and adopted the vision of serving as a trustworthy public guardian of food and drugs safety to
create a safe consumer environment. We shall continue to strengthen our capacities of food, drugs,
and cosmetics management and risk assessment, implement source management, ensure the
comprehensiveness of import management systems, and develop core testing technologies to attain
the ultimate goal of establishing a universal and consumer-oriented food and drug management.

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