Cabinet Decision Made on a Partial Revision of the Cabinet Order for the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.

News Highlights

On May 19, 2026, a partial revision of the Cabinet Order for the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. was decided by the Cabinet. This revision may affect the management systems for chemical substances that medical institutions may handle. Specifically, changes are anticipated in the regulations concerning the screening of new chemical substances and the manufacture/import of existing chemical substances. This is expected to further increase the demand for compliance in areas such as safety management of pharmaceuticals and reagents, waste disposal, and research and development activities within medical institutions.

M&A Medical Editorial Department’s Perspective

The recent cabinet decision on the partial revision of the Cabinet Order for the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. may, at first glance, seem unrelated to the direct management challenges of medical institutions. However, the potential for strengthened regulations on a wide range of chemical substances used daily by medical institutions, including pharmaceuticals, diagnostic reagents, and disinfectants, cannot be ignored. In particular, changes in regulations regarding the introduction of new chemical substances or the handling of previously permitted substances may necessitate a review of procurement processes, inventory management, and disposal methods. For instance, it is conceivable that obtaining certain reagents could become more difficult, or disposal costs could increase. Medical institutions that cannot quickly adapt to these changes risk not only increased compliance violations but also potential disruptions to their clinical practice and research activities. From an M&A perspective, the extent to which a target medical institution can or has the capacity to comply with these regulatory changes can be a critical evaluation item during due diligence. Medical institutions with low regulatory compliance capabilities may present unexpected costs and risks during post-M&A integration, thus requiring careful assessment.

Key Discussion Points from This News

• Strengthened chemical substance regulations may impact medical institutions’ procurement, management, and disposal processes for pharmaceuticals and reagents.
• Changes in the screening of new chemical substances and the handling of existing substances will raise the bar for compliance.
• Delays in responding to regulatory changes risk disruptions to clinical practice and research activities, as well as increased costs.
• Evaluating the target medical institution’s capacity to comply with chemical substance regulations will be crucial in M&A due diligence.

Practical Questions Arising from This News

• What specific chemical substance regulations will change with this revision of the Cabinet Order?
• Will there be any impact on the pharmaceuticals and reagents currently used at our institution?
• What specific measures can be taken to comply with the regulatory changes, and where can we find expert consultation services?

If You Feel “I Should Consult Too?”

We recommend that you consult with an expert to confirm whether the chemical substances handled by your institution may become subject to new regulations or require changes in handling procedures due to this legal revision. In particular, you may need to review processes related to the introduction of new pharmaceuticals, the use of specialized reagents, or waste disposal. If you are considering M&A or business succession, such compliance risks can affect transaction valuations and integration processes. To understand your institution’s compliance status with the legal amendments and to mitigate future risks, please consider consulting with an expert.

M&A Medical (CentralMedience Inc.) supports the business succession of medical corporations, hospitals, and clinics as a business succession support institution certified by the Small and Medium Enterprise Agency, with a completely success-fee-based system. Consultations are accepted with strict confidentiality. Free consultation here