Taiwan FDA...near term marketing Belviq in Taiwan (courtesy wanderer4ever on IV MB)
TFDA (Taiwan Food and Drug Administration)
While following through today's Arena announcement, I found very interesting article. You can Google it also if you want to read full text. Just type my subject line. What is so interesting is that Belviq can be marketed in Taiwan immediately; within 7 to 14 days! I read Dragonsaurus asked when Ildong could launch Belviq in Korea. Ildong has to do clinical trial with Koreans before submitting NDA to Korean FDA. But in Taiwan, the TFDA can issue license to market the drug pending full evaluation of U.S. FDA approval documents. That is how I read it. If it is not correct, someone can correct me.
"........To streamline the review process, for new drugs with new ingredients that have received market approval from the U.S. Food and Drug Administration (FDA) or the EU’s European Medicine Agency, the TFDA will refer to the overseas evaluation reports and carry out high-spot review of racial differences and marketing risk controls.
In regard to the simplification of clinical trial review, to encourage the simultaneous marketing of new drugs in Taiwan the Department of Health will speed up review for multi-national and multi-center clinical trials that are carried out jointly in Taiwan and medically advanced countries. At the fastest, approval will be granted in seven to 14 days.
In addition, the TFDA and the Center for Drug Evaluation set up an integrated Medicinal Product Review Office (MPRO) in June of 2011 to strengthen the consistency of case control and review. The new office uses the single-window approach and simultaneous review through a division of labor by professional field, together with an internal control mechanism, to boost review performance
Maybe not that fast: "the Department of Health will speed up review for ... trials that are carried out jointly in Taiwan and medically advanced countries." Sorry guys I don't remember a B trial in Taiwan. OTOH, doesn't meant DoH won't speed up its review on its own.
Sentiment: Strong Buy