| To get new drugs on the market faster and
bring relief to Taiwan’s sufferers, as
well as to stimulate the development
of the biotechnology industry, the Department
of Health (DOH) is speeding up the premarket review of new
drugs. The review period for drugs that have been approved by
the United States or the EU will be cut in half.
The DOH explains that the
review process for new drugs that have already won
approval from the Food and Drug Administration (FDA) of the U.S.
or the European Medicines Agency (EMA) of the EU will be
simplified so that Taiwanese disease sufferers will be able to
enjoy their benefits simultaneously with international users.
Drug companies will not have to wait for review by the drug
advisory committee but will be able to send the relevant
information to the Food and Drug Administration of Taiwan’s
DOH, which will carry out a review focusing on the foreign
evaluation reports, whether or not the new drug contains any
racial differences, and whether or not it is suitable for the
people of Taiwan to use.
For the pricing of new drugs,
in the past the company concerned
had to obtain a domestic certificate of
pharmaceutical product and then apply to the Bureau of National
Health Insurance (BNHI) for National Health Insurance (NHI) drug
price approval. From December of 2010, however, a company can
submit an application to the BNHI for a new-drug price after
obtaining an approval letter from the DOH and carry out pricing
discussions first, so that the price can be approved immediately
after the certificate of pharmaceutical product is issued. This
is expected to reduce the time needed for NHI approval of
new-drug prices from the three months of the past to just two
months today.
Clinical trial review is also being simplified. In the past,
many clinical trials were either fully or partially completed
overseas before being continued in
Taiwan. To make it easier to put new drugs on the market in
Taiwan, and to do so simultaneously with their marketing
overseas, when transnational clinical trials are being carried
out abroad, or when multi-national, multi-center clinical trial
programs are being carried out jointly by
Taiwan and other medically
advanced countries, the DOH will
evaluate only whether they conform to
ethical principles and the interests of domestic
disease sufferers, with no technical data review. This will
greatly shorten the review timetable
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