Introduction to the New Revisions
According to the news (厚労省・佐藤審議官 次期薬機法改正に込めたメッセージ「製薬産業・薬局は国民から信頼される産業に」 | ニュース | ミクスOnline) released by MixOnline as date of 01/08/2025, Daisaku Sato, Director-General of the Ministry of Health, Labour and Welfare (MHLW), highlighted the guiding principle behind the upcoming revisions to the Pharmaceutical and Medical Device Act. The revisions aim to establish a pharmaceutical industry that ensures stable and reliable access to medicines for the public. The proposed amendments focus on addressing ongoing compliance issues, strengthening manufacturing oversight, and improving drug accessibility at various stages.
Addressing Challenges in Drug Access Across Three Stages
The MHLW’s Pharmaceutical Affairs and Medical Device System Council has identified three critical issues to be resolved in the drug access process:
Upstream Drug Lag and Loss: This includes delays in introducing innovative drugs to the Japanese market.
Midstream Supply Challenges: Problems such as shortages in generic drug supply have brought attention to manufacturing-related vulnerabilities.
Downstream Distribution: Focused on the “last mile” challenges in the commercial distribution process, including pharmacy and distribution inefficiencies affecting patient access to medicines.
The legislative revisions aim to tackle these challenges comprehensively, ensuring better drug availability and accessibility.
Strengthening Compliance and Oversight in Manufacturing
The amendments address the recent surge in compliance violations, particularly among generic drug manufacturers. Key measures include:
Introducing authority for regulatory bodies to mandate changes in responsible executives within pharmaceutical companies.
Enhancing the oversight framework for contract manufacturers to ensure adherence to quality and compliance standards.
Defining clear responsibilities for manufacturing and marketing authorization holders, including periodic reviews and data collection for quality assurance.
Additionally, quality and safety management roles, previously defined at the ministerial ordinance level, will now be codified into law, providing greater clarity and enforceability.
Improved Conditional Approval System
One of the hallmark changes is the revision of the conditional approval system, aligning it more closely with global standards like the FDA’s Accelerated Approval system. Under the new rules:
Conditional approvals can be revoked if the efficacy is not confirmed in the follow-up trials.
The eligibility criteria for conditional approval will be broadened to include drugs with “reasonably predictable clinical usefulness.” This adjustment will attract more international ventures, particularly startups, by creating a supportive regulatory framework.
Post-Marketing Safety Measures and Real-World Data Utilization
Post-marketing safety measures will be emphasized in the new legislation. These include:
Mandating submitting and implementing Risk Management Plans (RMPs) to manage post-marketing risks effectively.
Promoting the use of Real-World Data (RWD) for post-marketing epidemiological studies, transitioning towards evidence-based, scientifically valuable safety monitoring.
The changes reflect a shift towards leveraging digital transformation (DX) in healthcare, ensuring Japan’s regulatory framework remains agile and data-driven.
Promoting International Access and Innovation
The revisions also prioritize aligning Japan’s regulatory environment with global standards, addressing concerns of foreign companies seeking to enter the Japanese market. Enhanced regulatory flexibility and efficiency are expected to reduce drug lag, encouraging faster access to innovative treatments.
Conclusion
Japan’s forthcoming Pharmaceutical and Medical Device Act revisions represent a significant step toward modernizing the regulatory environment. By addressing drug access challenges, strengthening manufacturing oversight, and aligning with global standards, the new legislation seeks to enhance patient care and foster pharmaceutical innovation. These changes hold promise for international pharmaceutical companies aiming to expand their presence in the Japanese market.
