Introduction to Legislative Progress
According to news (薬機法等改正法案 参院厚労委で賛成多数で可決 15項目の附帯決議採択 14日にも成立へ | ニュース | ミクスOnline) released by MIX Online on May 14, 2025, Japan’s House of Councillors Health, Welfare and Labour Committee passed significant amendments to the Pharmaceutical and Medical Device Act (PMD Act). The bill, supported by ruling and opposition parties, is expected to be formally enacted by the Upper House on May 14. Alongside the bill, 15 supplementary resolutions were adopted, highlighting areas where the government is expected to take further action in the implementation phase.
Stricter Requirements for Conditional Approvals
The amendment stipulates concrete deadlines and content requirements for post-marketing confirmatory clinical trials to ensure the reliability of drugs approved under the conditional approval system. If sponsors fail to submit the required data without valid justification, regulatory authorities will be expected to revoke the approval. This is a key shift toward aligning Japan’s practices with global norms.
Reinforced Post-Marketing Safety Measures
The legislation calls for enhanced safety monitoring plans for conditionally approved products. These measures must be specified at the time of approval and include stronger pharmacovigilance protocols to ensure the timely identification and management of adverse effects.
Clearer Information Disclosure to Patients and HCPs
One of the new mandates includes enhanced transparency regarding conditionally approved drugs. Pharmaceutical companies must clearly state that such products are approved under special conditions and that confirmatory trials are ongoing or incomplete. This applies to drug labels and informational materials, promoting informed decision-making among healthcare professionals and patients.
Cautious Use of Real-World Data (RWD)
While real-world data is increasingly being considered in global regulatory frameworks, the supplementary resolution emphasizes that RWD should not replace randomized clinical trials. It stresses the need for robust infrastructure and clear standards before RWD can play a more central role in Japan’s drug approval process.
Governance Reform in Marketing Authorization Holders (MAHs)
The government will retain the authority to issue orders for management changes in MAHs, but the resolution advises careful implementation. Instead of abrupt enforcement, the focus should be encouraging voluntary internal reform, protecting business continuity while ensuring compliance.
Permanent Access to Emergency Contraceptives
In line with recommendations from the UN Committee on the Elimination of Discrimination against Women, the resolution urges the government to ensure nationwide availability of emergency contraceptives through pharmacies. Issues such as age restrictions and pricing must be addressed for equitable access.
Conclusion
Japan’s newly approved PMD Act amendments aim to tighten oversight of conditional drug approvals, enhance post-market safety, and improve patient information transparency. With further discussions expected during implementation, these revisions signal a shift toward a more accountable and globally harmonized regulatory system.