Japan: New Mandatory Pharmaceutical Risk Management Requirements Under the Amended PMD Act

Introduction

Japan is introducing significant changes to its pharmaceutical regulatory framework, including new statutory requirements for pharmaceutical Risk Management Plans (RMPs), strengthened quality assurance and safety management responsibilities, and additional measures concerning pharmaceutical supply management.

The amended Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the Amended PMD Act), which will come into force on 20 May 2027, introduces a statutory obligation to prepare and implement RMPs in specified circumstances.

Previously, RMP requirements were established through ministerial regulations and implemented as conditions of approval for individual pharmaceutical products. Under the amended legislation, the preparation, reporting and implementation of RMPs will become express statutory requirements.

To support these changes, Japan’s Ministry of Health, Labour and Welfare (MHLW) issued new ministerial orders and regulatory guidance on 30 September 2026.

This article examines the new RMP requirements, the circumstances in which they will apply, and the additional regulatory changes affecting pharmaceutical quality assurance, post-marketing safety management and supply systems.

1. Mandatory Risk Management Plans Under the Amended PMD Act

The Amended PMD Act introduces new provisions requiring pharmaceutical marketing authorization holders (MAHs) to prepare and implement RMPs where necessary to ensure the safety and efficacy of pharmaceutical products.

Historically, RMPs were not expressly provided for under the PMD Act. Instead, their definitions and associated activities were established through the Ministerial Orders on Standards for Post-Marketing Safety Control of Pharmaceuticals, Quasi-Pharmaceutical Products, Cosmetics, Medical Devices and Regenerative Medicine Products (the GVP Ministerial Orders).

RMPs were implemented as conditions of approval for individual pharmaceutical products.

Following the legislative amendment, the preparation and implementation of RMPs will be required directly under the PMD Act.

On 30 September 2026, the MHLW promulgated ministerial orders amending the relevant regulations in connection with the partial enforcement of the amended legislation (the Amendment Orders).

These amendments establish detailed provisions concerning the new RMP requirements within the Regulations for Enforcement of the PMD Act and introduce corresponding changes to the GVP Ministerial Orders.

On the same date, the MHLW issued two additional notifications:

• Overview of Risk Management Plan (Pharmaceutical Affairs Division Notification No. 0930-13, dated 30 September 2026).

• Guidance on the Risk Management Plan and on the Handling of the Preparation and Publication of the Risk Management Plan (Pharmaceutical Safety Division Notification No. 0930-1, dated 30 September 2026).

Together, these measures establish the regulatory framework for the preparation, implementation and management of RMPs under the amended legislation.

2. Overview of Pharmaceutical Risk Management Plans

An RMP is intended to ensure that pharmaceutical risks are appropriately identified, monitored and managed throughout a product’s lifecycle, from development through to post-marketing use.

It consolidates relevant risk management activities into a single document, enabling ongoing assessment as research, clinical studies and risk minimization measures progress.

Each RMP addresses three principal areas:

• Safety specifications: Identification of important safety concerns associated with a pharmaceutical product.

• Pharmacovigilance activities: Activities undertaken to collect and evaluate safety information following marketing authorization.

• Risk minimization activities: Measures designed to reduce pharmaceutical risks, including information provided to healthcare professionals and conditions governing the use of particular products.

Safety specifications identify important known risks, important potential risks and important areas where safety information remains insufficient.

For each identified concern, corresponding pharmacovigilance and risk minimization activities are developed and incorporated into the RMP.

These activities are divided into two categories.

Routine activities are measures that MAHs undertake for pharmaceutical products generally. They include collecting information about adverse drug reactions and providing safety information through package inserts and other standard communications.

Additional activities are product-specific measures introduced where the characteristics or risks of a particular pharmaceutical require further action.

Examples include early post-marketing phase vigilance (EPPV), use-results surveys, post-marketing clinical studies and the distribution of materials designed to promote the appropriate use of medicines.

Once prepared, RMPs are published on the website of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

3. Key Changes to Risk Management Plan Requirements

The amended framework introduces several important changes affecting when RMPs are required, how additional risk minimization measures are assessed and the circumstances in which an RMP may be terminated.

Circumstances Requiring an RMP

Under Article 68-2 of the Amended PMD Act, MAHs will be required to prepare, report and implement an RMP where this is considered necessary to ensure pharmaceutical safety and efficacy.

For prescription pharmaceutical products, excluding in vitro diagnostics, an RMP will be required in any of the following circumstances:

• Additional pharmacovigilance activities are undertaken.

• Additional risk minimization activities are implemented.

• Safety information concerning specific events or patient populations is collected, or studies and tests relating to efficacy are conducted, including other similar circumstances.

The new guidance also clarifies when the need for an RMP must be considered.

This assessment is not limited to applications for approval of new pharmaceutical products or biosimilars.

It must also be considered when new safety concerns arise in relation to products for which no RMP has previously been prepared, or where an existing RMP has already been terminated.

This approach reinforces the importance of ongoing risk assessment throughout the commercial lifecycle of pharmaceutical products.

Assessment of Additional Risk Minimization Activities

The amended framework places particular emphasis on evaluating whether additional risk minimization activities are effective.

With the exception of information provision through EPPV, the effectiveness of additional risk minimization activities must be assessed.

The evaluation considers several factors:

• Whether relevant information and materials have reached the intended healthcare professionals and patients.

• Whether the information has been recognised and understood, contributing to improved knowledge.

• Whether the information has resulted in actions intended to avoid or reduce identified risks.

• Whether the measures have produced an actual risk reduction or demonstrable improvement in risk management.

The guidance also addresses methods for evaluating effectiveness.

These may include questionnaires, interviews and the use of medical information databases, alongside requirements concerning the planning and reporting of effectiveness assessments.

The provisions place greater emphasis on evaluating the practical impact of risk minimization activities rather than simply confirming that relevant information has been distributed.

Termination of an RMP

The amended framework also clarifies the circumstances in which an RMP may be terminated.

An RMP may be brought to an end where all activities relating to safety specifications, efficacy specifications and the RMP itself have been completed.

The MAH must also determine that the relevant specifications can be removed from the RMP.

Where these conditions are satisfied, termination may proceed following consultation with the PMDA.

4. Additional Regulatory Changes Under the Amendment Orders

Beyond the introduction of statutory RMP requirements, the Amendment Orders establish further provisions affecting pharmaceutical quality assurance, manufacturing oversight, post-marketing safety management and supply systems.

The amendments clarify the responsibilities, authority and independence of designated personnel, together with requirements concerning documentation, internal procedures, record retention and regulatory reporting.

Several matters previously addressed through operational practices under the Good Quality Practice (GQP) and GVP Ministerial Orders are now more expressly incorporated into the regulatory framework.

Statutory Appointment of a Pharmaceutical Quality Assurance Supervisor

Article 17(6) of the Amended PMD Act introduces a statutory requirement to appoint a pharmaceutical quality assurance supervisor.

The individual appointed must satisfy several requirements, including:

• Having the necessary capability to perform and oversee pharmaceutical quality assurance responsibilities effectively.

• Being responsible for the quality assurance division.

• Having at least three years of relevant experience in quality control operations or related activities.

• Maintaining appropriate independence and neutrality, including independence from the sales department.

The role includes responsibilities established under the GQP Ministerial Orders, together with duties arising from the supervisor’s statutory authority.

The amended provisions also require copies of written opinions submitted to the marketing director to be retained for five years.

These requirements formalise the position of the quality assurance supervisor and reinforce the independence and accountability of pharmaceutical quality management functions.

Strengthened Oversight of Manufacturing-Related Operations

Article 18(3) of the Amended PMD Act strengthens the responsibilities of MAHs in supervising manufacturing-related operations.

MAHs must confirm that manufacturing control and quality control activities are appropriately conducted at pharmaceutical manufacturing sites and other facilities engaged in manufacturing-related operations.

They must also document and retain the results of these confirmations.

The amended regulations clarify that facilities undertaking manufacturing-related operations include those conducting testing, inspections and other activities associated with pharmaceutical products intended for marketing.

The criteria governing these confirmations have also been clarified.

These provisions reinforce the responsibility of MAHs to maintain appropriate oversight of manufacturing and quality control activities across relevant facilities.

Statutory Appointment of a Pharmaceutical Safety Management Supervisor

The Amended PMD Act also introduces a statutory requirement to appoint a person responsible for pharmaceutical safety management under Article 17(6).

The designated individual must meet requirements relating to professional capability, experience and organisational independence.

These include:

• Having the ability to appropriately oversee post-marketing safety management activities.

• Being responsible for the safety management division or safety assurance division.

• Having at least three years of relevant experience in post-marketing safety management activities when appointed by a Type 1 pharmaceutical MAH.

• Maintaining independence from the sales department.

The appointed individual must carry out the responsibilities prescribed under the GVP Ministerial Orders, together with duties associated with their statutory authority.

Copies of written opinions submitted to the marketing director must also be retained for five years.

The changes provide a clearer statutory basis for pharmaceutical safety management responsibilities and associated governance requirements.

5. New Requirements for Pharmaceutical Supply Management

The amended legislation introduces additional requirements concerning the management of pharmaceutical supply systems.

Under Article 18-2-2 of the Amended PMD Act, MAHs of specified pharmaceutical products will be required to appoint a designated pharmaceutical supply system manager.

The appointed individual must satisfy several conditions, including:

• Having the necessary ability to perform supply system management responsibilities appropriately and effectively.

• Possessing at least three years of relevant practical experience.

• Maintaining independence from other designated managers and the quality and safety divisions.

The new position is intended to provide clear responsibility for the management and oversight of supply-related activities involving specified pharmaceutical products.

Responsibilities of the Pharmaceutical Supply System Manager

The designated manager will have several statutory responsibilities.

These include:

• Overseeing pharmaceutical supply system management activities in accordance with the relevant procedural manual.

• Confirming that supply management activities are being performed appropriately and effectively, and maintaining records of those confirmations.

• Determining necessary corrective or other measures and providing instructions to relevant departments or responsible individuals.

• Issuing written communications or instructions, where necessary, to manufacturers, foreign manufacturers, wholesale distributors, pharmacies, hospitals, clinics and other relevant parties.

• Retaining copies of relevant written communications and carrying out other duties prescribed under the amended legislation.

The manager must also retain written opinions and relevant records for five years.

Additional responsibilities include coordinating with the marketing director, quality assurance supervisor and pharmaceutical safety management supervisor.

Obligations of Marketing Authorization Holders

The amended provisions also impose further organisational responsibilities on MAHs of specified pharmaceutical products.

These include:

• Preparing and maintaining procedural manuals governing pharmaceutical supply system management.

• Clearly defining the authority and responsibilities of the designated supply system manager.

• Providing appropriate education and training.

• Establishing information management arrangements to support timely and accurate reporting and regulatory notifications.

These requirements seek to establish a clearer internal framework for managing pharmaceutical supply responsibilities and ensuring appropriate coordination between relevant regulatory functions.

Conclusion

The amendments to Japan’s PMD Act represent an important development in the regulation of pharmaceutical risk management, quality assurance, safety oversight and supply systems.

The introduction of statutory RMP requirements establishes a clearer legal basis for the preparation, implementation and evaluation of pharmaceutical risk management activities.

At the same time, the new provisions concerning quality assurance supervisors, pharmaceutical safety management personnel and supply system managers formalise key responsibilities and strengthen requirements relating to governance, operational oversight and record retention.

For pharmaceutical MAHs operating in Japan, the changes introduce a more structured regulatory framework with defined responsibilities across multiple aspects of pharmaceutical operations.

With the amended legislation scheduled to come into force on 20 May 2027, affected businesses will need to consider the implications of these requirements for their existing risk management processes, internal governance arrangements and regulatory compliance procedures.

Selected regulatory references:

• Ministry of Health, Labour and Welfare – Regulatory Amendment Materials

• Pharmaceuticals and Medical Devices Agency – Risk Management Plans

• Pharmaceuticals and Medical Devices Agency – RMP Framework

By Anderson Mori Tomotsune, Japan, a Transatlantic Law International Affiliated Firm. 

For further information or for any assistance please contact japan@transatlanticlaw.com

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