Issuance of Joint Statement "Clinical Trial Ecosystem Industry Declaration 2025

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November 20, 2025
Japan Pharmaceutical Manufacturers Association
American Association of Research Pharmaceutical Manufacturers and Associations
European Federation of Pharmaceutical Manufacturers and Associations
Japan CRO Association

The Japan Pharmaceutical Manufacturers Association (JPMA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Japan CRO Association (JCROA) have issued a joint ^statement*1 entitled "Clinical Trials Ecosystem Industry Declaration 2025 The statement is aimed at improving the international competitiveness of the clinical trial environment.

Drug Lag/Loss in Japan

In Japan, new drugs that have already been approved and marketed overseas remain unapproved in Japan, causing a serious problem in which patients are unable to receive necessary treatment. 245 of the new drugs marketed in the US and Europe between 2014 and 2023 have not been marketed in Japan as of November 2024, Of these new drugs, 124 (51%) were not yet in development in Japan. In addition, 70% of new drugs in late-stage clinical development in Europe and the U.S. have not yet been developed in ^Japan*2, indicating an increase in "drug lag," which means a delay in drug approval in Japan compared to other countries, as well as "drug loss," which means that drugs are not developed in Japan in the first place. This is a further increase in the "drug loss" problem, which means that drugs are not developed in Japan in the first place. Currently, the government, the medical industry, and industry are cooperating in various efforts to solve the "drug lag/loss" issue.

Setting Clear Goals for Increasing Participation in International Clinical Trials

One of the factors contributing to the drug lag/loss is the low participation rate of Japan in international clinical trials. Currently, the mainstream of drug development is to conduct international joint clinical trials involving various countries in order to promote development simultaneously around the world, and to apply for approval in each region and country based on the results of the trials. Therefore, it is said that participation in international joint clinical trials leads to the approval and marketing of new drugs at the same time as other countries. According to the interim report by the "Conceptual Council for Prompt Delivery of the Latest Drugs to the Public through Enhanced Drug Discovery," the goal is to increase the number of initial notifications of global clinical trials (notifications submitted at the time of new drug development) to 150 by 2028, 1.5 times the number of notifications submitted in 2021.

More Efficient Operation of Clinical Trials

One of the reasons for Japan's low participation rate in global clinical trials is that, although Japan's clinical trial environment fully meets the criteria for participation in global clinical trials, the operational complexity and cumbersome procedures unique to Japan, compared to Western countries, are factors that impair the efficiency of clinical trials. In FY2024, the Pharmaceuticals and Medical Devices Agency (PMDA) launched the "Project to Promote the Introduction of a Clinical Trial Ecosystem" to address these issues. This project aims to establish a "clinical trial ecosystem" that enables more efficient operations while maintaining the quality of clinical trials through collaboration among various parties involved in clinical trials.

Optimization and streamlining of the clinical trial implementation system

The four organizations are cooperating with the government and the medical industry to optimize and streamline Japan's clinical trial implementation system in order to improve international competitiveness and increase the number of global clinical trials conducted in Japan. As part of this effort, we are addressing issues related to the quality of clinical trials, and have compiled a joint statement on matters to optimize and streamline the implementation of clinical trials as an industry. The statement declares that the industry will review procedures that are not implemented in other countries and are excessively implemented only in Japan, focus resources on important matters, and emphasize dialogue with medical institutions conducting clinical trials. To further stimulate discussion among industry representatives, we plan to hold a workshop in 2026.


We will continue to promote our activities with the principles of this statement in mind so that Japan will become an indispensable country in the simultaneous development of new drugs worldwide in order to bring more medicines to Japanese patients as quickly as possible.

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