hina and Japan, two large economies in Asia, have shared a long and intricate history of cultural exchange and mutual influence dating back to ancient times.

In the realm of drug development, their relationship was “chilly” for a long time. The two countries had very different approaches to the internationalization of drug development, which resulted in little dialogue until recently. This article discusses several actions taken by the authors to enhance this dialogue against the backdrop of the two countries’ efforts to align their drug regulations with international norms.

Historic and Parallel Changes in Drug Development

Japan’s capability in drug development earned it a seat on the International Council for Harmonisation (ICH), established in 1990, as one of the founding members alongside the European Union and the United States. The country aligned its clinical trials with international standards when its health authority (the Ministry of Health, Labour and Welfare [MHLW]) adopted the ICH GCP Guideline in the Ministerial Ordinance in 1997. Later on, the country’s policy to enhance participation in multiregional clinical trials (MRCTs) was articulated in the MHLW Notification Basic Principles on Global Clinical Trials (2007).

China’s pharmaceutical regulatory system was different from that employed in Western countries. However, a pivotal shift began in 2015 with the State Council’s statement Reform of the Drug and Medical Device Evaluation and Approval System (Guo Ban Fa No. 44), which initiated the internationalization and harmonization of drug regulation in China. The State Council statement clearly described China’s intent to modernize its drug registration system by introducing new ideas such as a definition of “new drug,” accelerating reviews of NDAs/INDs (New Drug Applications/Investigational New Drug applications), and regulatory harmonization. Other key milestones quickly followed, including China’s formal accession to ICH in 2017, which visibly reflected the presence of China in the international pharmaceutical ecosystem; the Opinions on Deepening the Reform of Review & Approval System to Encourage Innovation in Drugs and Medical Devices (No. 42), which described a concrete plan to update drug regulations, also issued in 2017; and the 2019 Drug Administration Law Revision, a full revision of the pharmaceutical law to complete the evolutionary innovation of the drug registration system in China. China accomplished in three to four years what took Japan nearly 20 years to achieve.

Iyaku Kenpatsu Tatsujin (Yiyao Yanfa Daren in Chinese, Pharmaceutical R&D Experts in English) Laid the Groundwork for Bilateral Communication

This internationalization has created an environment where people in both nations can speak a common language with regard to drug regulation.

The authors started working together to launch an initiative in July 2021: the online media outlet Iyaku Kenpatsu Tatsujin (Pharmaceutical R&D Experts) was designed to help pharmaceutical industry information flow between Japan and China. Articles and updates were published twice a month until 2024 on a website run by the Chinese biopharmaceutical industry media outlet PharmaDJ (which supported this activity by providing their platform) and were also posted on the popular Chinese social networking service/site WeChat. The articles in this initial phase were mostly about Chinese pharma industry news to be provided to the Japanese industry in the Japanese language.

The Japanese edition of Tatsujin was published until March 2024, when PharmaDJ changed its position to temporarily stop website support for this activity. However, right after that, interest had been sparked and in response to growing demand from rapidly internationalizing Chinese drug firms, a Chinese edition of Tatsujin, called “Yiyao Yanfa Daren: Chuhai Riben” in Chinese (in English: Pharmaceutical R&D Experts: Go Abroad to Japan), was launched in February 2025. This Chinese edition provides Japan-related industry information in the Chinese language for Chinese readers, printed and delivered by mail twice a month, continuing this grassroots advocacy for communication and friendship between these two countries. There is no Japanese-language edition at this time.

Sessions Reflect the Growth of Chinese Drug Companies

Sessions at two recent DIA China Annual Meetings (CAM) have also enhanced this bilateral relationship and reported on the remarkable growth of Chinese drug companies as well as their engagement in and with Japan.

The CAM 2023 session Japan as the Next Destination: Demystify the Japanese Regulations presented the results of a survey conducted by the authors in collaboration with the Pharmaceutical Innovation and Research Development Association (PhIRDA) of China. The association’s member companies were canvassed about their priorities regarding foreign countries in the context of the strategies to expand their market to other countries in the world (Figure 1).

Figure 1. Analysis of Chinese companies’ prioritized countries/regions (presentation by Zhang Zhijuan (PhIRDA) at the DIA China Annual Meeting 2023).

This survey indicated that Chinese biotech companies ranked Japan as their fourth priority as a venue of clinical trials after the US, EU, and Australia, and their third priority, after the US and EU, in terms of product launch (see above). It is important to note that at this point (in 2023), no drugs originating in China had been approved in Japan, although one or two had been approved in the US and Europe.

Speakers and organizers of the “Going to Japan” Session I at the DIA China Annual Meeting 2023 from left to right: Donglei Mao (PharmaDJ), Ling Su (Shenyang Pharmaceutical University), Akio Uemura (AU Consulting), Tetsuomi Takano (Fortrea), Wendy Yan (BeiGene), Yuko Kikuchi (Eisai), Fei Liang (EPS Creative Health Technology), and Yan Tang (CJMMIC).

By the time the Japan-China session The Japanese Pharmaceutical Industry Demystified was presented two years later, at CAM 2025, the atmosphere around these discussions had changed completely and the enthusiasm from the China drug development community was palpable.

Table 1. Update on recent China-originated new drugs in Japan (presentation by Akio Uemura (AU Consulting) at the DIA China Annual Meeting 2025).

By this time (only two years later), four new drugs from China had been approved and launched in Japan, and China had initiated several phase 3 clinical studies in Japan (Table 1). While a certain rise of Chinese drug companies in Japan was expected, this progress in the blossoming relationship between Japan and China seems remarkable.

Speakers and supporters of the “Going to Japan” Session II at the DIA China Annual Meeting 2025 from left to right: Akio Uemura (AU Consulting), Yoshiaki Uyama (PMDA), Kenichi Nakamura (National Cancer Center), Tetsuomi Takano (t2T Healthcare), Jin Li (Henlius Biotech), Yiming Du (Haihe Biopharma), Fei Liang (EPS Creative Health Technology), Ling Su (Lilly Asia Ventures), and Donglei Mao (PharmaDJ).

As a reference, we searched for similar information about Japanese drugs approved in China during 2023-2025. Table 2 shows that Japanese companies are also very active in pursuing development opportunities in China. The magnitude of the development efforts by Japanese companies is still higher compared to that of Chinese companies, but we expect that Chinese activities in Japan will reach the same level in the near future.

Table 2. List of products developed by Japanese companies and approved in China (2023-2025).

With both the NMPA and PMDA implementing policies to encourage MRCTs and streamline regulatory pathways, the stage is set for accelerated transactions between China and Japan. Given the genetic and disease profile similarities in their populations, particularly in oncology, autoimmune disorders, and metabolic diseases, the coming years will likely see a surge in cross-border licensing deals and joint clinical development. More Chinese biotechs will establish local operations in Japan, while Japanese firms deepen partnerships to access China’s innovation pipeline. Regulators and industry must continue to work together, building a bridge between China and Japan. The progress since 2023 proves that when these two neighbors collaborate, patients on both sides stand to benefit.