The use of Real-world Data (RWD) to produce appropriate Real-world Evidence (RWE) as a basis or supplement for drug efficacy or safety data is in the ascendant.
The Food and Drug Administration of the Ministry of Health and Welfare wrote this guide with reference to international norms and related documents and invited industry and academia experts to form a working group to conduct case studies, hoping to support manufacturers or academia in the use of such materials as drug development or use changes. When providing information, be guided.
The main purpose of this guide is to introduce the characteristics of real-world evidence and the basic considerations of its application and to explain the establishment of real-world evidence and the test design methods for generating real-world evidence.
This guideline provides a broad and general description of the application of real-world evidence in drug development. In the future, other relevant guidelines will be developed as needed for the industry’s reference.
This guideline is the current view of regulatory agencies on the use of real-world evidence to support drug research and development and explains important considerations when using real-world evidence in drug registration review decisions. This guideline is not a statutory or compulsory one.
Applicants are responsible for choosing the research method that is most suitable for their products, and other appropriate methods can be used for research in accordance with the key considerations suggested in this guideline. In addition, the monitoring and auditing of real-world research using real-world data is not within the scope of this guide.
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