Real-World Evidence is Gaining Ground Globally, Albeit Unevenly

The use of real-world evidence (RWE) and real-world data (RWD) in regulatory decision-making has grown worldwide in recent years, but this growth has not been even. For example, while the US set up an RWE framework in 2018, Switzerland only put out a preliminary RWE guidance this July. APAC nations are also increasingly adopting guidances for the use of RWE, with some countries ahead of others.

According to Mary Ellen Schneider, “In China, the National Medical Products Administration (NMPA) developed three guidelines between 2020-2021 on the use and evaluation of RWE for drug development and regulatory decisions, addressing pediatric drug development as well as RWD quality and data security.”

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(Source: Regulatory News, September 20^th, 2022)