There is a growing global level of activity and planning around the use of Real World Evidence (RWE). For example, it has been used to improve the design of clinical trials and to support post-approval drug efficacy and safety. Many health authorities around the world have formulated and implemented guidance on the applications of the RWE. In order to support and supervise this new development, the TFDA referenced relevant guidelines in other countries and took into account of the situations in Taiwan and completed the guideline on the review of RWD/RWE-based applications.
Sponsors who intend to submit an RWE-based application are advised to communicate with the regulatory authority as early as possible so as to ensure the trial design and data collection and analysis will be incompliance with the regulatory requirements.