On May 14, 2025, the Act Partially Amending the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc. and Related Laws was enacted. The amended Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc. (the "amended PMD Act") and the amended Medical Care Act (the "amended Medical Care Act") are to be brought into force in stages, and part of the amendments has already come into effect as of November 20, 2025. The key points of the amendments are outlined below.

1. Reinforcement of Quality Assurance and Safety Measures for Pharmaceuticals, etc.

Key Amendments

(1) Orders to Change Responsible Officers

In order to address failures by responsible officers to remedy illegal situations or illegal acts led by responsible officers, the amended PMD Act now allows the authorities to order the replacement of responsible officers of marketing authorization holders or manufacturers of pharmaceuticals, etc., when it is particularly necessary to prevent the occurrence or spread of health hazards, including the violation of laws and regulations on pharmaceutical affairs by any responsible officer (Article 72-8 of the amended PMD Act).

(2) Appointment of a Pharmaceutical Quality Assurance Manager

The requirement to appoint a Pharmaceutical Quality Assurance Manager, which had previously been provided for in the Ministerial Ordinance on Standards for Quality Management of Pharmaceuticals, Quasi-drugs, Cosmetics, and Regenerative Medical Products (the GQP Ordinance), is now stipulated in the amended PMD Act (Article 17(6) of the amended PMD Act). In addition, Pharmaceutical Quality Assurance Managers are now also subject to the order for replacement as described in (1) above (Article 73 of the amended PMD Act).

(3) Appointment of a Pharmaceutical Safety Control Manager and Mandatory Preparation of a Pharmaceutical Risk Management Plan

The requirements to appoint a Pharmaceutical Safety Control Manager and to prepare a Pharmaceutical Risk Management Plan, which had previously been provided for in the Ministerial Ordinance on Standards for Post-Marketing Safety Management (the GVP Ordinance), are now stipulated in the amended PMD Act (Article 17(6) of the amended PMD Act). Pharmaceutical Safety Control Managers are now also subject to the order for replacement as described in (1) above (Article 73 of the amended PMD Act).

(4) Post-Approval Performance Evaluation of In-Vitro Diagnostics

For in-vitro diagnostic pharmaceuticals that detect viruses or similar agents, performance may be affected by mutations of such viruses after approval. Accordingly, in order to ensure that performance is maintained not only at the time of approval but also after marketing, a framework similar to the re-evaluation system for pharmaceuticals has been introduced. This includes provisions requiring marketing authorization holders to collect, evaluate, and report information, and allowing for revocation of approval where performance is not adequately ensured (Article 23-2-10-2 of the amended PMD Act).

2. Supply of Quality-Assured Ethical Drugs, etc.

Key Amendments

(1) Establishment of Systems by Marketing Authorization Holders of Prescription Drugs to Ensure Stable Supply

From the perspective of ensuring a stable supply system for prescription drugs, the amended PMD Act requires marketing authorization holders to undertake initiatives to secure a stable supply and to appoint a person responsible for managing the stable supply system. In addition, necessary measures to ensure stable supply (for example, the preparation of standard operating procedures for securing a stable supply system) are stipulated as compliance requirements (Article 18-2-2 of the amended PMD Act).

(2) Notification and Reporting Obligations under the Amended PMD Act

Marketing authorization holders of Specified Pharmaceuticals (which generally correspond to prescription drugs) (Article 2(17) of the amended PMD Act) are required to report the risk of shipment suspension or restriction where shipment of such Specified Pharmaceuticals is to be suspended or restricted, or there is a risk thereof, within 6 months (Article 18-3 of the amended PMD Act). In addition, where shipment has in fact been suspended or restricted, a notification of shipment suspension or restriction must also be submitted (Article 18-4 of the amended PMD Act).

(3) Measures to Ensure Stable Supply under the Amended Medical Care Act

With respect to Specified Pharmaceuticals, the Minister of Health, Labour and Welfare is now empowered to:

• request cooperation from marketing authorization holders, manufacturers, and wholesale distributors, to increase production, coordinate sales, and provide other cooperation necessary to ensure the provision of the relevant Specified Pharmaceuticals or alternative drugs; and
• request cooperation from pharmacies, hospitals, clinics, and other medical institutions to dispense or prescribe and provide other cooperation necessary to ensure the provision of medical care to persons who require the relevant Specified Pharmaceuticals or alternative drugs (Article 36 of the amended Medical Care Act).

Furthermore, the Minister of Health, Labour and Welfare may designate "Supply Assurance Pharmaceuticals" and "Important Supply Assurance Pharmaceuticals," and may instruct their marketing authorization holders and manufacturers to formulate guidelines to ensure stable supply, to take measures to prevent supply shortages, and to increase production, among other measures (Articles 37, 38, and 38-2 of the amended Medical Care Act). As of November 10, 2025, 762 active ingredients have been designated as Supply Assurance Pharmaceuticals, and 75 active ingredients have been designated as Important Supply Assurance Pharmaceuticals (MHLW Notification No. 292).

3. Improvement of Drug Discovery and Regulatory Environments to Eliminate Drug Lag and Drug Loss

Key Amendments

(1) Use of Real-World Data

From the perspective of promoting the use of real-world data, the scope of data to be submitted as attachments to applications for approval of pharmaceuticals, medical devices, etc. has been revised. Specifically, the statutory wording has been changed from "data on the results of clinical trials and other data" to "data on quality, efficacy, and safety as specified by Ministry of Health, Labour and Welfare ordinances" (Article 14(3) of the amended PMD Act).

(2) Review of the Conditional Approval System for Pharmaceuticals, etc. for Rare and Serious Diseases

The scope of cases eligible for conditional approval has been relaxed from cases where the product is "an orphan drug, a pioneering drug, a drug for a specific use, or otherwise deemed to be of particularly high medical necessity, and where it is difficult to conduct clinical trials involving a sufficient number of subjects to verify the efficacy and safety of the pharmaceutical," to cases where it is "deemed to be of particularly high medical necessity and can reasonably be expected to have the indications and effects applied for." In addition, if it becomes impossible to verify efficacy, etc. after approval, revocation of the approval will be permitted (Articles 14-2-2(1), 23-2-6-2(1), 74-2(1) of the amended PMD Act).

(3) Promotion of the Formulation of Development Plans to Address Drug Loss for Pediatric Pharmaceuticals

Recognizing that the development of pediatric pharmaceuticals has generally been slow and that efforts to improve the development environment remain insufficient, the amended PMD Act provides that marketing authorization holders of pharmaceuticals are required to make efforts to formulate development plans for pediatric pharmaceuticals and to collect the necessary data in accordance with such plans (Article 14-8-2 of the amended PMD Act).

4. Revision of Pharmacy Functions and Pharmacist Services and Promotion of Proper Use of Pharmaceuticals

Key Amendments

(1) Sales of pharmaceuticals through remote management by pharmacists and others using digital technology

With the widespread use of real-time communication tools using video and audio, the amended PMD Act allows OTC pharmaceuticals to be kept at stores which can be controlled by a pharmacist remotely, and be delivered to purchasers in an environment where pharmacists are available to provide consultation and service, even if the pharmacist is not physically stationed at the store (Article 29-5 of the amended PMD Act).

(2) Institutionalization of Partial Outsourcing of Dispensing Operations

In order to allow pharmacy pharmacists to focus on interpersonal services, the amended PMD Act permits pharmacies, subject to permission from the prefectural governor or other competent authority having jurisdiction over the location of the pharmacy, to outsource part of their dispensing operations (Article 9-5 of the amended PMD Act).

(3) Addition of Online Medication Guidance for Designated Guidance Pharmaceuticals

Previously, Designated Guidance Pharmaceuticals were limited to face-to-face sales. Under the amended PMD Act, online medication guidance has also been permitted (Article 36-6(1) of the amended PMD Act).