Regulations and Status of Early Clinical Trials of Medicinal Products in Taiwan
The development and use of medicinal products are strongly associated with the health and safety of citizens and demand rigorous regulation. Investigational new drugs must be regulated at different levels according to risks if they are to be used in clinical trials. The design and highquality conduction of early clinical trials is the key to the subsequent large-scale pivotal trials of investigational medicinal products and can be considered as an indicator to measure the biomedical innovation ecosystem. Limited by the scale of domestic market and the resources of research and development, the status of early clinical trials in Taiwan needs to be promoted. To facilitate the progress, the Taiwan Food and Drug Administration revised relevant guidelines and regulatory measures. It is expected that the industry will invest more resources in Taiwan to conduct early clinical trials and to develop new drugs, thereby benefiting the health and well-being of the public.