The planned Taiwan Food and Drug Administration (TFDA) will be formally inaugurated January 1, 2010 and have a staff of 500 people, Minister without Portfolio Chang Jin-fu announced on October 12, 2009.
At a meeting of the Executive Yuan’s committee on strategies to develop the biotechnology industry, Chang said that one of the new institution’s major tasks will be to set drug production standards and regulations in line with those in other countries in the region, including China, Japan and South Korea.
The initiative is an important part of Taiwan’s preparations to introduce the country’s biotech sector in the international market, he said, because it will make products developed in Taiwan more marketable.
At the meeting, Yang Shun-tsung, an Executive Yuan Science and Technology Advisory Group researcher, explained that Taiwan needs the international market to support the high upfront costs in the biotech sector because of the limitations of its own small domestic market.
If domestic regulations and manufacturing standards conform to those in the regional market, it can save additional testing costs, Yang said.
Citing Switzerland as a model, Yang said that when a new drug is approved there, it can directly enter the markets of 17 other countries.
“If Taiwan targets the Asian market as its major buyer, it must refer to the relevant laws and regulations of countries like China, South Korea and Japan,” the researcher said.
On the same occasion, Kuo Ming-liang, head of the National Science Council’s Department of Life Sciences, revealed that the government is working to form two biotech clusters to help transform Taiwan into a global medical engineering application and manufacturing center.
The clusters will be located in the Hsinchu Biomedical Science Park in northern Taiwan and in the Southern Taiwan Science Park in the south, Kuo said.
The government hopes these clusters will help Taiwan boost its output of medical equipment and devices to NTD250 billion ($7.74 billion) in 2015.
Kuo pointed out that Taiwan’s medical equipment production sector had a compound growth rate of 14.24% between 2003 and 2008, a rate of growth higher than the world average.
“It shows the great ambition of Taiwanese businesses,” he said.
Local producers of medical equipment and devices have never been properly integrated, however, which is why the government is playing an active role in bringing them together and helping them develop products that have potential on the market.
Kuo said the Hsinchu Biomedical Science Park will cater to the development of sophisticated high-end medical equipment and devices in cooperation with the strong semiconductor and communications manufacuturers in the neighboring Hsinchu Science Park.
As to the planned southern Taiwan medical equipment cluster, the government intends to gather makers of products with dental, orthopedic or plastic surgery applications, Kuo said.
They will be helped by the many hardware, precision instrument, and chemical material manufacturers in the Kaohsiung area, he added.