Taiwan’s Bureau of Pharmaceutical Affairs, a section of the Department of Health, is working on plans to raise clinical trial review fees for New Chemical Entities (NCEs) from the current level of about $1,500 to about $18,300, or somewhere in between. No specific increase has been decided on to date. The Center for Drug Evaluation (CDE), which manages pharmaceutical registration, said that the whole process costs the government $15,240 on average, and labor costs alone make up $2,740 of that. It is not yet clear to the drug industry whether such a dramatic change will actually be implemented.
The CDE emphasized that clinical trial review fees are currently much lower in Taiwan than in other countries. In the US, FDA clinical trial review fees for NCEs are over $600,000, while equivalent fees in the EU are over $300,000. The CDE plans to use the increased fees to improve efficiency and reduce review time. Although the process of obtaining Investigational New Drug status in Taiwan has been reduced to approximately 30 days, the full New Drug Application process still takes twelve months or more.
A final decision has not been made yet, as the Bureau of Pharmaceutical Affairs is still negotiating and reviewing the fee changes with international pharmaceutical companies. However, the government does not seem likely to change its basic intent. The Minister of Health stated publicly on August 14, 2006 that they hope the fees will be used to better fund CDE operations. Therefore, drug companies who will require clinical trials to get product approval in Taiwan may want to start their trials before the new fees are implemented.