Regarding the Release of the Joint Statement “Clinical Trial Ecosystem Industry Declaration 2025”

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November 20, 2025
Japan Pharmaceutical Manufacturers Association
Pharmaceutical Research and Manufacturers of America (PhRMA)
European Federation of Pharmaceutical Industries and Associations (

EFPIA)

Japan CRO Association (JCROA)

The Japan Pharmaceutical Manufacturers Association (JPMA), Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), andthe Japan CRO Association (JCROA) have issued ^{a joint statement*1} titled “Clinical Trial Ecosystem Industry Declaration 2025—Addressing Quality Challenges and Aiming to Optimize and Streamline Clinical Trial Operations”— with the goal of enhancing the international competitiveness of the clinical trial environment.

The Current State of Drug Lag/Loss in Japan

In Japan, a serious problem has arisen in which new drugs already approved and marketed overseas remain unapproved domestically, preventing patients from receiving necessary treatments.Of the new drugs sold in Europe and the United States between 2014 and 2023, 245 products were not available in Japan as of November 2024; of these, 124 (51%) had not yet entered development in Japan.Furthermore, 70% of new drugs in late-stage clinical development in Europe and the United States ^{have not yet entered development} in ^Japan*2. This indicates an increase in challenges beyond the “drug lag”—which refers to delays in drug approval compared to other countries—to include “drug loss,” which means that drugs are not being developed in Japan in the first place.Currently, various initiatives are underway to address the challenges of “drug lag” and “drug loss” through collaboration among government agencies, the healthcare sector, and industry.

Setting Clear Targets for Increased Participation in International Clinical Trials

There are multiple factors contributing to “drug lag/loss,” and one of these is Japan’s low participation rate in international clinical trials.In today’s pharmaceutical development landscape, the mainstream approach involves conducting international clinical trials with participation from various countries to advance development simultaneously worldwide, and then using the results to submit approval applications to each region and country. Therefore, it is said that participating in international clinical trials leads to the approval and sale of new drugs at the same time as in other countries.The interim report from the “Conceptual Planning Meeting to Rapidly Deliver the Latest Pharmaceuticals to the Public by Enhancing Drug Discovery Capabilities” sets a target of increasing the number of initial clinical trial notifications for international multi-center trials (notifications submitted when developing new drugs) to 150 by 2028—a 1.5-fold increase from the 2021 level.

More Efficient Operation of Clinical Trials

One reason for Japan’s low participation rate in international clinical trials is that, although Japan’s clinical trial environment sufficiently meets the standards for participation in such trials, operational complexities and cumbersome procedures unique to Japan—compared to Western countries—are factors that undermine the efficiency of clinical trials. Starting in fiscal year 2024, the Pharmaceuticals and Medical Devices Agency (PMDA) launched the “Project to Promote the Introduction of a Clinical Trial Ecosystem” to address these challenges.This initiative aims to build a “clinical trial ecosystem” in which diverse stakeholders involved in clinical trials collaborate to enable more efficient operations while maintaining the quality of clinical trials.

Optimization and Streamlining of the Clinical Trial Implementation System

Our four organizations are also cooperating with this initiative and collaborating with government agencies and the healthcare industry to enhance Japan’s international competitiveness by optimizing and streamlining the country’s clinical trial implementation framework, thereby increasing the number of international joint clinical trials conducted in Japan.As part of these efforts, we are addressing issues related to the quality of clinical trials and have compiled a joint statement outlining measures for the industry to optimize and streamline clinical trial operations.We have declared our commitment to reviewing procedures that are not implemented in other countries but are carried out excessively in Japan, concentrating resources on critical matters, and prioritizing dialogue with medical institutions conducting clinical trials. To further stimulate discussion among industry representatives, we plan to hold a workshop in 2026.


To deliver more medicines to Japanese patients faster, and to ensure that Japan becomes an indispensable partner in global simultaneous new drug development, we will continue to advance our activities guided by the principles of this statement.

　

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