Around the Globe

Real-World Evidence Regulatory Landscape in Asia Pacific: Australia, China, Japan, South Korea, and Taiwan
Ellen Sem
Fengyun (Vicky) Han
Annetta C. Beauregard
Janssen Pharmaceutical Companies of Johnson & Johnson

eal-world data (RWD) and real-world evidence (RWE) have played an increasingly important role in regulatory decision making in recent years. RWE has been commonly accepted by regulators for post-marketing safety surveillance activities but less so in the pre-marketing authorization phase. However, the pandemic provided an opportunity for regulators to assess the applicability of RWE to enable emergency use authorization or conditional approval of COVID-19 vaccines.

According to a statement issued by the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators collaborated and shared knowledge in assessing RWE generated from observational studies which complemented the evidence generated from clinical trials conducted on potential therapeutics or vaccines against COVID-19. With regulators gaining more experience in applying RWE for pre-marketing authorization, regulatory agencies in Asia Pacific have started to develop new regulatory policies and guidance documents regarding the use of RWE to support development of pharmaceutical products. This article summarizes the RWE regulatory landscape in the Asian-Pacific markets of Australia, China, Japan, South Korea, and Taiwan.


No formal regulatory guidance regarding RWE is currently available in Australia. In November 2021, the Therapeutic Goods Administration (TGA) published the report Review of real world evidence and patient reported outcomes, which provides insights on TGA’s position on RWE and patient reported outcomes (PRO). The report concluded that RWE already underpins TGA’s post-marketing safety studies on medicines, vaccines, and medical devices: TGA accepts the inclusion of RWE and PROs in submissions and assesses them during the pre-market review process. However, TGA recognizes that there could be better communication internally and externally on how TGA uses RWE and PROs in pre-market approval of products. The report highlights key next steps that TGA intends to undertake, including providing more clarity and transparency on how RWE and PROs can support approval applications and how TGA uses RWE and PROs in making decisions.


The RWE regulatory landscape in China has been dynamic and rapidly evolving, with the National Medical Products Administration (NMPA) leading this trend into drugs for pediatrics and other special populations. In August 2018, the Wu Jieping Medical Foundation released China’s Real World Research Guide, and several articles explaining the application of RWD including technical specifications, research design, data management, and statistical analysis were published in July 2019 by the China Real World Evidence Alliance (ChinaREAL). This Alliance was established in 2017 to help promote use of RWE for healthcare and policy decisions through partnerships with regulatory authorities, research scientists, and other stakeholders. To date, NMPA has published three RWE guidelines:

NMPA, industry, and academia continue to engage; for example, a three-year NMPA RWE project aims to study worldwide RWE policies, collect use cases, and research data standardization. The upcoming annual NMPA RWE conference will further share research results and exchange of best practices among international professionals, and help the local regulatory landscape grow more multidisciplinary. These research results and use cases will also provide the scientific basis for new RWD/RWE regulatory guidelines in the future. These stakeholders are also discussing big data, digital health, personal information protection and cybersecurity, and other relevant areas that could influence future regulatory policy or guidance.


The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) are actively promoting the utilization of RWD and RWE in their regulatory decision-making processes. In 2014, PMDA published its first RWD-related Guidelines for the Conduct of Pharmacoepidemiological Studies in Drug Safety Assessment with Medical Information Databases. Between 2017 and 2021, both MHLW and PMDA released a series of documents related to post-marketing studies in Japan:

In April 2021, the PMDA established its RWD working group to discuss regulatory issues related to RWD/RWE, such as data reliability standards and methodological approaches, and seeks to continuously promote utilization of RWD in the Japanese regulatory framework. PMDA published a summary of results of studies utilizing the medical information database network MID-NET, which evaluates the safety of drugs based on electronic medical information accumulated and registered by daily medical practice in medical institutions.

South Korea

The Ministry of Food and Drug Safety (MFDS) has displayed keen interest in leveraging RWE for regulatory decision making, even with no formal RWE regulatory framework established, and has developed a comprehensive roadmap by sequentially expanding the scope and implementation of RWE utilization:

The Korea Comprehensive Plan for Drug Safety Management (2020-2024) anticipates that MFDS will continue this momentum by building a local ecosystem to leverage innovative technology including RWE to support new drug development.


RWE has become increasingly relevant in regulatory decision-making in Taiwan, with the Taiwan Food and Drug Administration (Taiwan FDA) issuing numerous guidelines (all Chinese text only):

Based on the comprehensive scope of these guidance documents, the Taiwan FDA appears to have high interest in improving local procedural and methodological practices to advance regulatory-quality RWE in Taiwan.


Within the region, only China, Japan, and Taiwan have adopted RWE-related guidelines. No formal regulatory framework is available in Australia or South Korea and through other related agencies. The approaches adapted by China’s NMPA, Japan’s PMDA, and Taiwan’s FDA also differ slightly:

  • In China, NMPA’s RWE guidance discusses the use, evaluation, and scope of RWE in China during drug development and lists several scenarios in which RWE may be used to support drug development and regulatory decisions. NMPA also released guidance specific to the use of RWE to support pediatric drug development.
  • In Japan, PMDA’s RWE guidance focuses on leveraging post-marketing studies and registry data for product approval applications.
  • Taiwan FDA’s RWE guidance discusses how RWE can complement traditional randomized clinical trials for rare diseases or new indications.
  • Data reliability and ensuring that data is of high quality and fit for purpose is a common theme among these three agencies.

There have been multiple efforts across Asia Pacific to enhance the use of RWE for regulatory decision making and RWE research is under discussion in other Asian-Pacific markets, with several workshops or research activities presented in Singapore, Malaysia, Hong Kong, India, and Thailand. The region is expected to collaborate with other international agencies to ensure a more coordinated RWE environment around the world.


The authors express appreciation to these individuals for their contributions to this article:

Alicia Ham
Janssen-Cilag Pty. Ltd.
Mingcan Du
Janssen Pharmaceutical Companies of Johnson & Johnson
Yumi Wakabayashi
Janssen Pharmaceutical Companies of Johnson & Johnson
HyunJin Kim
Janssen Korea Ltd.
Mico Shih
Johnson & Johnson Taiwan Ltd. (Janssen Taiwan)
Yee Ling Tan
Johnson & Johnson Taiwan Ltd. (Janssen Taiwan)
Chong Xiang Tan
Janssen Pharmaceutical Companies of Johnson & Johnson