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FDA touts Taiwan’s medical R&D strength


(Source: Taiwan Today 2014-2-21)

Taiwan is the first country to approve the anti-cancer drug Afatinib for use, demonstrating that the country is building up strength in biotechnology, the Food and Drug Administration under the ROC Ministry of Health and Welfare said Feb. 20.

“Taiwan’s biotech industry has become firmly established in the past decade or so, with record numbers and quality of clinical trials in 2013, proving that the hard work of industry, officials, academics and researchers has paid off,” the FDA said.

The bureau said that Afatanib, which targets lung cancer, has been undergoing clinical trials around the world, with National Taiwan University Hospital playing a leading role in second and third stage trials. “This is the first time that Taiwan was ahead of Europe and the U.S. in approving Afatanib.”

The nation is also active in the global response to the H7N9 bird flu outbreak originating in mainland China. Domestic firms and research bodies are heavily involved in vaccine R&D and production, with National Health Research Institutes most likely to begin human clinical trials later this year. The FDA said it has initiated a rolling review system to better facilitate vaccine development.

Work is also progressing on vaccines to treat meningococcal disease, especially the country’s most prevalent B strain, for which there is no effective vaccination, unlike the A, C, Y and W135 strains, the FDA said. Taiwan research bodies have produced an experimental vaccine and two years ago applied to conduct the first trials in humans. They were given the go-ahead by the FDA last year.

International drug companies are also choosing Taiwan as a base for multination, multicenter clinical trials, further proof of international recognition of the nation’s high standards. A record 258 such applications were made to the FDA in 2013, of which about 70 percent were multicountry, multicenter studies .