Reported by Lin Hui-Cin from Taipei

International pharmaceutical companies continue their investment in Taiwan, focusing mainly on clinical trials.  The MOHW receives over 300 applications of clinical trials every year.  Among them, about 70% are multi-center trials (which must include A10 countries).  This figure shows that Taiwan has the ability and environment for conducting world-class clinical trials.  The MOHW has been proactively bringing the regulatory system into line with international practices, expediting the new drug review system and creating a friendly environment.

Dr Kang Jaw-Jou, Director of the School of Pharmaceutical Science of the National Yang Ming University, pointed out that international pharmaceutical companies started involving Asian countries in their R&D activities in year 2000.  In this competition, Taiwan outperformed Singapore due to higher healthcare quality and a bigger population base.  Taiwan is now well known in the world for the quality of phase I safety clinical trials; and the quality of Phase II efficacy and dosage trials are also highly praised.

Dr Kang also pointed out that Taiwan has the advantages of transparent pharmaceutical regulations, a relatively fast drug review process and the market security provided by the NHI system.

The standard review procedure for a clinical trial application is 45 days, about the same as in other countries.  In order to attract more companies to include Taiwan in their multi-center clinical trial projects, the MOHW has shortened the review procedure to 15 days for the applications of multi-center clinical trials which include at least one of the A10 countries and involve medical centers in Taiwan.

The MOHW also announced the “Measures for Improving the Review Process for Drug Clinical Trial Proposals” in 2017.  Those measures introduce the simplified review process for first-in-human clinical trial proposals and the expedited review mechanism for cell/gene therapy clinical trial proposals.  By strengthening the tiered management and streaming assessment of applications of clinical trial proposals, those measures help to increase Taiwan’s competitiveness.

According to the MOHW officials, there are currently 128 GCP-certified teaching hospitals in Taiwan which are qualified for conducting clinical trials with credibility and quality.  Taiwan became a PIC/S member last year and an ICH regulatory committee member in June this year. The membership helps to create a robust regulatory environment in Taiwan.

MOHW officials also stressed the importance of the various pathways for new drug review.  For example, if the drug has been approved in at least two countries of the EU, the US and Japan, the review procedure can be shortened by half.

【2018-10-11/Liberty Times】