Pharmaceutical Affairs Committee
Interview with Chair Kashiwatani
Strengthening drug discovery" and "ensuring a stable supply of pharmaceuticals" are extremely important themes for the Japanese pharmaceutical industry and, by extension, for the health of the Japanese people. However, numerous challenges lie ahead in the process of realizing these goals, from the viewpoints of regulation and international competitiveness. The Pharmaceutical Affairs Committee conducts research and studies on various regulatory issues, such as the operation of the Pharmaceuticals and Medical Devices Act, approval screening, and safety measures, and makes policy recommendations from the standpoint of R&D-oriented pharmaceutical companies. The committee also discusses the challenges identified in the "Study Group on Drug Regulations to Enhance Drug Discovery Capability and Ensure Stable Supply," which was compiled in 2024, and how we should confront the growing "drug lag/drug loss. We asked Yuji Kashiwatani, chairman of the committee, about future prospects.
How should the pharmaceutical system change and what should it be like?
Should we aim for international harmonization?
There are many issues such as "drug lag/drug loss.
The Pharmaceutical Affairs Committee is responsible for making policy recommendations on various aspects of pharmaceutical administration, such as improving the efficiency of corporate activities and speeding up the approval process. From the standpoint of R&D-oriented pharmaceutical companies, the committee investigates issues related to the operation of the system and lobbies for improvements in order to improve the drug discovery environment in Japan.
Underlying these activities is a philosophy of always confronting the history of drug-related accidents and putting the safety of the Japanese people first. On top of that, we believe that our mission is to strike a balance between how to deliver superior pharmaceutical products to patients as quickly as possible.
Recent discussions have highlighted several issues. One is the "misinterpretation" between the government and the industry in deregulation. For example, when the deregulation of Phase I trials on Japanese subjects was announced, some companies incorrectly interpreted the deregulation to mean that Phase I trials were no longer necessary. Because the government and the PMDA (Pharmaceuticals and Medical Devices Agency) are taking an aggressive stance, the pharmaceutical industry needs to be mature enough to correctly understand the background and intent of the deregulation and make a judgment.
The designation of orphan drugs is also a frustrating situation. Although our efforts have led to an increase in the number of designations, the lack of resources on the review side has resulted in the institutionalization of a new category of priority face-to-face advice and non-priority review items. This means that the original goal of delivering drugs to patients with rare diseases as early as possible cannot be achieved, and the increase in the number of designated items has simply resulted in an increase in the number of items that enjoy preferential treatment in terms of drug prices. This is a structural problem of insufficient man-hours at PMDA, and we need to work together to find a solution.
Another pressing issue in Japanese healthcare is "drug lag/drug loss. The essence of the problem of innovative drugs that have been approved overseas but are not available in Japan is that "treatments that are accessible overseas are not accessible in Japan. It is necessary to discuss this issue not only as a problem of unapproval, but also as an option for patients to access treatments through clinical trials and other means.
Quality-related international consistency is also a serious issue. Although it is not impossible for quality to be unified in Japan, the U.S., and Europe from the perspective of no racial differences, differences in pharmaceutical regulations in each country will affect the quality, and for example, international harmonization of pharmacopoeias in each country has been discussed for more than 30 years.
We will continue to review and improve the existing system.
To overcome these challenges and bring Japan's drug discovery capabilities back to the world's highest level, we must operate and reform the system from a long-term perspective.
One option to address drug lag/loss is a system of "conditional approval," which would allow drugs approved overseas to be utilized in Japan in a timely manner. Of course, there are concerns such as data reliability, but we should seek ways to maximize patient benefits while managing risks. What is important is for the government to verify whether once a drug is approved, it will be continuously supplied to patients five or ten years from now, leading to improvements in the system.
Recently, there was an event in which a product approved with a conditional expiration date was removed from the NHI market. We must not let this end as a mere "failure. The government and companies should work together to deeply analyze the reasons why efficacy could not be verified, and apply this information to the future selection of products and methods of operation of the system.
The utilization of real-world data will also be key in the future. First, we should steadily build up a track record in areas such as revision of package inserts, and over the long term, we should use AI and other means to ensure the reliability of the data and envision a future in which the data can be used in new drug approval applications.
Starting with the "Study Group on Regulations for Strengthening Drug Discovery and Securing Stable Supply," we were able to discuss the existing systems in depth. In the future, we would like to continue to stop and review the need for improvement, looking at systems that have not yet received attention and asking "Is this really a system that still works?
The structure and activities of the Pharmaceutical Affairs Committee are posted on the website of the Pharmaceutical Manufacturers Association of Japan. Please visit the site.
[Pharmaceutical Affairs Committee website]
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