Page 8 - 2018食藥署年報(英文版)

and regulations, and enhanced the quality of drug manufacturing/processing to accomplish pharmaceutical
management. In 2017, the TFDA promulgated and implemented three “Refinement Measures on the Review
Process of Drug Clinical trial” to greatly shorten the review duration and to improve review efficiency.
Moreover, TFDA strived to establish a traceability system on medicinal products. In May 2017, this system was
officially released online to provide consultation and promotion services for business declaration. According to
the record, this online system provided consultation service for 1,700 individuals in the year of 2017. Moreover,
to ensure the quality and integrity of medicinal products throughout the storing and shipping process, TFDA
certified 275 Western medicinal product manufacturers/dealers to comply with GDP regulations. TFDA
also implemented comprehensive drug distribution management to ensure safe drug use and to fight against
adulterated drugs from entering the supply chain. In 2018, TFDA collected suggestions from businesses and
local Department of Health to keep on improving the declaration web page and user interface. In the meantime,
TFDA planned and analyzed the backstage management and statistical data to cooperate with inspections
carried out by local Department of Health, emphasize on drug supply chain management, and ensure safety
drug use.
Through Executive Yuan’s announcement of amending additional 14 controlled drugs in the regulation
and the encouragement of reporting improper use or abuse of addictive substances in clinical cases, TFDA
kept substances that are harmful to human health from entering the public. The new manufacturing facility for
controlled drug was completed on schedule in mid-2017, which was enlarged by 2.3 times. With this facility,
the supply of controlled drugs is now secured. In 2017, to combine novel innovations with anti-drug campaign,
TFDA held a hackathon competition for the first time with the theme of “Drug Prevention.”
It is also important to note that TFDA separated the regulations on medical devices from the
Pharmaceutical Affair Act, and drew up a separate law for medical devices to cover both industrial development
and the rights/interests of the consumers. The “Cosmetic Hygiene and Safety Act” was promulgated on
May 2 2018, which strengthened and improved the management framework for cosmetics. Moreover, with
the promulgation of 9 related regulations and announcements, which includes “Regulations governing 15
ingredients such as Safrole that are ingredients prohibited for use in cosmetic products,” our management on
cosmetics is moving forward to be in line with international trends.
In addition to the above achievements, TFDA also established a cross-departmental “Unlawful Food and
Drug Events Tackle Platform” and added a “Rumor Buster” section on the TFDA official website. The purpose
of this section is to clarify rumors and pass on proper food, drug and cosmetic knowledge by collecting various
folk prescriptions or news online, and responding with professional as well as correct information. Up until
now, over 300 myths had been debunked, allowing the public to receive accurate information promptly.
In the future, “Safe and effective medicinal products, safe and healthy food” will always be the primary
mission of TFDA. Under the vision of “Being a reliable guardian on food and medicinal product safety”
and “creating a safe food and medicinal consumer environment,” TFDA is committed to integrate source
management, effective monitor, and inspectional technology, as well as to maintain the core value of placing
consumers' safety in priority, which will eventually establish a new order on food, medicinal and cosmetics
management.

Director-General, Taiwan Food and Drug
Administration, Ministry of Health and Welfare