Real World Evidence (RWE) 201 – Revolutionizing Healthcare in Japan: The Rise of Real-World Evidence in Drug Development

RWE 201 – Revolutionizing Healthcare in Japan: The Rise of Real-World Evidence in Drug Development


Japan has several initiatives to support healthcare and drug development using real-world evidence (RWE). Pharmaceutical companies in Japan are increasingly using RWE to inform their decision-making, respond to requests from external stakeholders, and improve their therapies. They use advanced RWE analytics to identify previously unrecognized issues such as low treatment rates, late initiation, and the omission of large patient segments. This information can then be used to improve engagement with healthcare providers [1].

The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has recognized the importance of using real-world data (RWD) for regulatory purposes. Discussions regarding the acceptability of RWE for regulatory submissions have already been initiated [2]. The PMDA and the Ministry of Health, Labour, and Welfare (MHLW) have worked to promote the utilization of RWD/RWE throughout a drug’s life cycle [3].

There are also specific projects aimed at promoting the use of RWE in Japan. For instance, the Clinical Innovation Network (CIN) project, led by the MHLW and promoted by the Japan Agency for Medical Research and Development (AMED), aims to revitalize the clinical development of new drugs and medical devices in Japan by utilizing patient registries and cohort studies [4][5].

However, there are challenges to the use of RWE in Japan, such as limited access to data, difficulty in linking databases, poor data quality, unclear guidance on the acceptability of RWD/RWE by regulators, and lack of decision criteria, standards, and guidelines for RWE development [4].

Despite these challenges, the use of RWE in Japan is growing, and efforts are being made to overcome these obstacles. For example, the Japanese affiliate of one multinational pharma company used RWE data to shed light on the treatment journey of over 50,000 patients [1]. Another example is Chugai, a pharmaceutical company in Japan, which has conducted an exploratory study of efficacy and safety using anonymized electronic medical record information with the National Cancer Center Japan [6].









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