T 26: The Impact of Regulatory Policy on the Development of Clinical Trials in Taiwan

Poster Presenter

Jessica Chou

Section Chief
Taiwan Center For Drug Evaluation
Taiwan

Objectives

In order to protect patients and improve clinical trials, specific regulatory policies for clinical trial environment have been developing in Taiwan. This study is to review these indicators of the evolution of the clinical trial regulation and analyze their impact on clinical trial competitiveness.

Method

From 2009 to 2015, the database of reviewing investigational new drug applications in Taiwan was assessed to identify indicators of regulatory performance measurement. Also, the information of trials and sites for the treatment of major diseases in Taiwan was compared with other countries.

Results

The number of clinical trials in Taiwan has significant increase correlated with implementing new regulations and strategies through efforts of government, industry and academia. Particularly, the phase I and Phase III studies are growing greatly. 85% of the studies were sponsored by foreign companies. And, 70% were multiregional clinical trials. The major hospitals involved in clinical trials were given AAHRPP accreditation, IRB/c-IRB function and brought significantly more clinical trials to support new drug premarket approvals. Recently, fostering competitiveness of clinical research in Taiwan, such as speed of approval, patient recruitment, personnel experience and training, visibility of centers of excellence, has emerged.

Conclusion

Clinical trials offer critical path to discover new or promising therapies. The regulatory environment for clinical trials is considered to affect a company’s decision on multi-regional clinical trials. This study is intended to recognize clinical trial competitiveness in Taiwan induced by the evolution for the international harmonization of the GCP in Taiwan and strategies for streamlining clinical trial regulation. This study establishes the current regulatory performance and their impact on boosting clinical trials in Taiwan. The critical successful factors on fostering competitiveness of clinical trials require sustained monitoring and measurement.