Updated on 13 September 2013
The national government has supported the establishment of clinical research centers in hospitals and the Taiwan FDA (TFDA) has added a new fast-track review process for global and regional trials. Provided that a multinational clinical trial protocol has been approved by one of 10 reference countries, then the TFDA will undertake only an administrative review without requiring technical evaluation from the Centre for Drug Evaluation. Many international and local biopharmaceutical companies are initiating an increasing number of clinical trials in Taiwan, either in the form of local studies or as part of regional or global international multi-center studies. As in other markets, many sponsors outsource some or all of their Taiwan clinical studies to contract research organization (CRO).
In this regard, there are significant advantages in partnering with a CRO which has specialist experience of the medical, political, regulatory and cultural environment of Taiwan and the Asia Pacific region, regarding regulatory consultancy, strategy and planning, and advice, protocol design, development and communication, feasibility and site selection, patient recruitment and retention, pharmacovigilance, DSMB (safety monitoring and signal detection), and data management and statistical analysis (audit trail management).
Proactive expert support across these study areas can help to ensure that sponsors reap the multiple benefits associated with running trials in Taiwan while reducing the risk of delays and complications. Taiwan is a growing location for pharmaceutical studies and this will herald continuous challenges and opportunities for clinical development. In order to rise to these challenges, there is enormous potential for ethical and ambitious biopharmaceutical companies working in partnership with regional clinical research organizations that combine local expertise with the highest global standards of quality and service.