Pharmaceutical News
TFDA announces the guidance on using RWD/RWE to support drug applications
2021/07/10

At present, most of the data used to support the pre-marketing or post-marketing efficacy and safety of a drug come from the results of randomised controlled clinical trials.  With such trials, researchers are able to carefully control the variables which may undesirably affect the assessment; however, the strict recruitment and exclusion conditions and the requirements of frequent hospital revisits make it difficult to reflect the actual clinical environment.

In the real world, there are various clinical situations which are different from the designed trial conditions.  As a result, some products have been found less effective than expected after their launch.  Also, as the trial subjects are not able to represent the whole patient population, some very rare adverse drug reactions might not be detected during the clinical trials.  

Now, there is a growing global level of activity and planning around the use of Real World Data (RWD) and Real World Evidence (RWE). Many health authorities around the world have formulated and implemented guidance on the applications of the RWD/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 guidance on using RWD/RWE to support drug applications.

However, as there is no international standard to assess whether the RWD/RWE are fit for a particular purpose or use, the TFDA suggests that sponsors who intend to submit an RWD/RWE-based application should communicate with the regulatory authority as early as possible so as to ensure the trial design and data collection and analysis will be in compliance with the regulatory requirements.

The Guidance is applicable to (1) applications of clinical trials of investigational new drug; (2) new drug applications; (3) applications of post-approval changes; and (4) post-marketing requirements.  All RWD/RWE-based trials or researches are subject to the Medical Act, the Human Clinical Trial Act, the Pharmaceutical Affairs Act and other relevant regulations and orders. 

【2021-07-02 / TFDA News】