Implementation Dates of the Revised Pharmaceutical and Medical Device Act (PMD Act)

Legislative Process and Enactment

On March 19, 2019, the bill titled “Act to Partially Amend the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, etc.” was approved by the Cabinet and submitted to the National Diet. The bill did not pass during the 198th Ordinary Diet Session. Subsequently, deliberations continued during the Extraordinary Diet Session that convened on October 4, 2019. The bill was approved by the House of Councillors plenary session on November 27, 2019, and was promulgated on December 4, 2019 (hereinafter referred to as the “Revised PMD Act”).

This revision was initiated in response to the provision in the supplementary provisions of the Act on Partial Revision of the Pharmaceutical Affairs Act implemented five years earlier, which stipulated that the provisions following the revision should be reviewed approximately five years after implementation.

Purpose and Scope of the Revision

The Revised PMD Act contains elements that strengthen regulations on related companies. Therefore, it is essential to closely monitor future developments in ministerial ordinances and other detailed regulations. The revision encompasses a wide range of areas and multiple aspects. Consequently, the implementation dates vary depending on the content, with provisions to be implemented within one year, two years, or three years from the date specified by Cabinet Order.

Phased Implementation Schedule

According to the “Cabinet Order Establishing the Enforcement Date of the Act to Partially Amend the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, etc. (Cabinet Order No. 39 of 2020)” promulgated on March 11, 2020, the enforcement dates were designated as follows:

Implementation Phase	Enforcement Date	Major Content Areas
Phase 1	September 1, 2020	– Legal institutionalization of the “Sakigake (Priority Review) Designation System” and “Conditional Early Approval System”<br>- Legal stipulation of pharmacists’ obligations to monitor patients’ medication usage and provide medication guidance as needed, not limited to dispensing
Phase 2	August 1, 2021	– Mandatory establishment of legal compliance systems for licensed businesses<br>- Enhancement of post-market safety management<br>- Revision of GMP (Good Manufacturing Practice) Ministerial Ordinance<br>- Revision of QMS (Quality Management System) Ministerial Ordinance
Phase 3	December 1, 2022	– Mandatory display of barcodes and other identifiers on pharmaceutical and medical device packaging

Revisions to GMP and QMS Ministerial Ordinances

GMP Ministerial Ordinance Revision

The revision of the GMP Ministerial Ordinance was implemented in conjunction with the enforcement of the Revised PMD Act. Specifically, the “Ministerial Ordinance to Partially Amend the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Pharmaceuticals and Quasi-drugs (Ministry of Health, Labour and Welfare Ordinance No. 90 of 2021)” was promulgated on April 28, 2021, and came into effect on August 1, 2021.

This represented the first major revision in approximately 16 years since the previous GMP revision in December 2004. The key objectives of the revised GMP Ministerial Ordinance were:

1. International Harmonization: Alignment with PIC/S (Pharmaceutical Inspection Co-operation Scheme) GMP Guidelines to facilitate international standardization of pharmaceutical quality requirements
2. Implementation of Pharmaceutical Quality System (PQS): Introduction of ICH Q10 (Pharmaceutical Quality System) requirements, mandating establishment of comprehensive quality systems throughout the product lifecycle
3. Quality Risk Management: Incorporation of ICH Q9 principles, requiring systematic approaches to identifying, assessing, and mitigating quality risks
4. Organizational Structure Enhancement: Mandatory establishment of separate organizations for quality assurance activities and testing/inspection activities within the quality department
5. Data Integrity: Strengthened requirements for electronic record and document management to ensure data reliability and traceability

The revised GMP provisions require active involvement from top management in quality system establishment and implementation, representing a significant shift toward enterprise-wide quality assurance frameworks rather than site-specific approaches alone.

QMS Ministerial Ordinance Revision

Similarly, the QMS Ministerial Ordinance was revised to align with international standard ISO 13485:2016. The revision was implemented through multiple stages:

1. A major revision to Chapter 2 of the QMS Ministerial Ordinance was enacted in 2021 to achieve harmonization with ISO 13485:2016
2. A three-year transition period was provided for companies to adapt to the new requirements
3. The transition period concluded in March 2024, after which full compliance with the revised standards became mandatory

The revised QMS Ministerial Ordinance incorporates enhanced requirements including:

• Risk-based approaches to process management
• Software validation requirements for quality management systems
• Strengthened requirements for management review and continuous improvement
• Enhanced provisions for supplier management and outsourcing control

Background and Significance of the Five-Year Review

The requirement for review five years after implementation stems from a broader regulatory framework principle. When the Pharmaceutical Affairs Act was revised and renamed the Pharmaceutical and Medical Device Act (PMD Act) in 2014, the supplementary provisions stipulated that the government should examine the implementation status of the revised provisions approximately five years after enforcement and take necessary measures based on the examination results.

This periodic review mechanism ensures that pharmaceutical and medical device regulations remain responsive to:

• Advances in medical technology and innovation
• Changes in international regulatory standards
• Emerging safety concerns and quality issues
• Evolution in manufacturing and quality management practices
• Shifts in healthcare delivery models and patient needs

Contemporary Context and Industry Impact

The 2019 revision occurred against a backdrop of significant quality and compliance issues within the Japanese pharmaceutical industry. Between 2015 and 2020, several major incidents involving GMP violations came to light, including:

• Manufacturing irregularities at domestic pharmaceutical manufacturers discovered in 2015
• A nationwide inspection ordered in January 2016 that found 22,297 products (69% of all products) had minor deviations requiring post-approval notifications
• Serious contamination incidents in December 2020 involving generic drug manufacturers, where sleep-inducing agents were inadvertently mixed into antifungal medications

These incidents underscored the necessity for stronger regulatory frameworks and more robust quality systems, directly influencing the scope and stringency of the 2021 revisions to the GMP and QMS Ministerial Ordinances. The reforms emphasize not only technical compliance but also the establishment of corporate governance structures and quality cultures that prioritize patient safety.

Regulatory Compliance and Future Outlook

Companies subject to these regulations must maintain vigilance regarding:

1. Ongoing Regulatory Updates: Continue monitoring announcements from the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA)
2. International Harmonization Trends: Stay informed about developments in PIC/S, ICH (International Council for Harmonisation), and ISO standards that may influence future domestic requirements
3. Quality System Maturity: Invest in building robust pharmaceutical quality systems and quality risk management capabilities that go beyond minimal compliance
4. Corporate Governance: Strengthen legal compliance frameworks and establish effective internal control systems as mandated by the August 2021 provisions
5. Data Integrity: Implement comprehensive data governance practices aligned with global regulatory expectations

Summary and Conclusion

The Revised PMD Act represents a comprehensive modernization of Japan’s pharmaceutical and medical device regulatory framework. The phased implementation approach, with enforcement dates of September 1, 2020, August 1, 2021, and December 1, 2022, allowed regulated entities to systematically prepare for and adapt to new requirements.

The concurrent revisions to the GMP and QMS Ministerial Ordinances, implemented on August 1, 2021, constitute particularly significant changes that bring Japan’s manufacturing and quality standards into closer alignment with international best practices. These revisions reflect a paradigm shift from traditional compliance-focused approaches to more comprehensive quality system frameworks that emphasize risk management, lifecycle approaches, and active management engagement.

As the pharmaceutical industry continues to evolve with advancing technologies, increasing globalization, and heightened expectations for product quality and safety, regulatory frameworks must remain dynamic and responsive. Stakeholders should continue to monitor regulatory developments and maintain proactive engagement with evolving quality standards to ensure patient protection remains paramount while fostering innovation and access to high-quality pharmaceutical products and medical devices.