Written by Hsu Yu-Chun
Taiwan has elected two professionals with medical background as its new President and Vice President. The new government pledged to amend the “Technical Fundamental Law” and the “Act for The Development of Biotech and New Pharmaceuticals Industry” in order to open a new page in the development of the innovative biopharmaceutical industry and to gather the momentum for economic growth. However, the industry should not be under any illusion of immediate results, because new drug R&D is a costly and time consuming process. In addition to the government’s intention, the future of the biopharmaceutical industry relies heavily on the industry’s own efforts.
New drug development is the most profitable branch of the biopharmaceutical industry. It involves a relative high risk. To successfully develop a new drug is hard; but, it is even harder to bring it into the global market. As the domestic market is too small, and the NHI system has a profound impact on the profit level; to launch new products on the international market is every new drug developer’s ultimate goal.
This common goal will define the future direction of the new drug R&D in Taiwan. The regulations established by the TFDA are already more stringent than those imposed by the US FDA and the EMA. However, the TFDA’s criteria are not necessarily accepted by the international market, because so far, there has been no innovative new drug firstly launched in Taiwan. Therefore, most new drug developers in Taiwan resort to forming strategic alliance with foreign partners, and authorizing them to conduct clinical trials in the US or the EU.
Taiwan has a high capacity for new drug R&D with abundant professionals and specialists. Many promising new drugs are now at Stage III clinical trials. What’s lacking here is the RA professionals specializing in CRO, clinical trial planning, NDA, etc. This issue needs urgent actions.
【2016-01-22/ Wealth Invest Weekly】