Post-marketing drug safety practices differ across Japan, the US, and the EU particularly in how risk management is structured, how safety data is generated and used, and how extensively additional risk minimisation measures are applied.
When a medicinal product receives marketing authorisation, regulatory oversight continues through ongoing pharmacovigilance activities. Although global frameworks are broadly aligned, differences in implementation affect how safety signals are identified, assessed and acted upon in practice. This blog post examines the key differences in post-marketing drug safety practices across Japan, the US and the EU, as well as their practical implications for Marketing Authorisation Holders. See also our other blog on MAH’s post-authorisation pharmacovigilance responsibilities in the EU.
How post-marketing drug safety is monitored globally
Across all regions, post-marketing safety surveillance relies primarily on spontaneous adverse drug reaction (ADR) reporting systems. These are sometimes complemented by post-authorisation safety studies (PASS), either conducted voluntarily or required as part of regulatory commitments.
Regulatory authorities continuously evaluate accumulating safety data and may take action such as updating product information, restricting use, or, in some cases, withdrawing a product from the market.
However, important limitations remain. Unexpected adverse drug reactions may emerge only after widespread use, and post-authorisation studies do not always translate quickly into regulatory changes1. Delays in fulfilling these commitments have also been highlighted as a recurring challenge for Marketing Authorisation Holders.
How do post-marketing safety outcomes differ between regions
Evidence from the US and EU suggests that medicinal products approved through accelerated pathways may be more likely to face safety-related regulatory actions after approval. Earlier market entry can mean that less comprehensive safety data is available at the time of authorisation.
In contrast, Japan has historically experienced a “launch lag”, with products entering the market later than in the US or EU. This has allowed for more safety data to accumulate prior to approval, potentially resulting in more extensive product information at launch2.
More recent research suggests that these differences may be narrowing. Increasingly globalised drug development and near-simultaneous submissions have reduced launch delays but this also means that less overseas safety data is available at the time of approval in Japan.
A comparative study found no clear evidence that Japan is slower or less active in implementing safety-related labelling changes compared to the US and EU, further supporting the view that regulatory practices are converging3.
Japan’s evolving pharmacovigilance approach
Japan has taken significant steps to strengthen its pharmacovigilance system in recent years. The introduction of a formal Risk Management Plan framework in 2013 aligned Japan more closely with international practices and marked a shift from reactive surveillance to a more proactive approach. Subsequent reforms have emphasised the use of real-world data (RWD) and improved the scientific robustness of post-marketing studies4.
These developments have led to a more structured and forward-looking approach to safety monitoring, with fewer products showing unresolved safety or efficacy concerns after approval.
Comparison of post-marketing risk management approaches in the EU, US and Japan
While all three regions take extra steps for drugs with serious risks like teratogenicity or novel ADRs, their general risk management strategies differ in tone. The EU focuses on requiring Risk Management Plans for every new drug and necessary additional interventions when routine PV measures aren’t enough. Japan uses a similar system to the EU which requires a broad Risk Management Strategy for all new drugs. The US, meanwhile, reserves its formal REMS program for a select few high-risk drugs5.
When it comes to additional risk minimization measures; Japan applies additional risk minimisation measures to a larger share of medicinal products and addresses more safety concerns per product. In contrast, the US tends to focus on controlling access to high-risk products through REMS, while the EU typically adopts a balanced approach between information-based and control-based measures.
The more selective US approach may support faster access to new therapies, whereas the broader approaches seen in the EU and Japan may reflect a more precautionary stance towards public health through risk management.
These differences are not only regulatory but are also shaped by broader systemic and cultural factors. Although regulatory frameworks are aligned in principle, their implementation reflects how risk is perceived and managed within each region.
This includes differences in healthcare system structures, regulatory culture and risk tolerance, the availability and use of real-world data, and historical approaches to patient safety5.
What this means for Marketing Authorisation Holders
For companies operating globally, these differences have clear practical implications. A single, standardised pharmacovigilance approach is unlikely to meet regional expectations. Instead, Marketing Authorisation Holders must:
- adapt risk management strategies to regional requirements
- align post-authorisation study designs with local expectations
- anticipate differences in additional risk minimisation measures
- ensure that safety data generation supports both global and local regulatory needs
Understanding these nuances early can help avoid delays, reduce regulatory risk, and support smoother lifecycle management.
With over 20 years of experience in pharmacovigilance, Medfiles has supported more than 90 clients across the EU, the US and Asia. We help you to ensure that pharmacovigilance systems are both compliant and fit for purpose in each region. This includes developing and maintaining PV systems aligned with regulatory requirements, preparing and updating Risk Management Plans, supporting post-authorisation studies and real-world data strategies, and advising on regional expectations to ensure that safety activities are fully integrated into broader regulatory and lifecycle strategies.
Author: Arda Sanaktekin, Drug Safety Expert
Arda Sanaktekin joined the Medfiles Pharmacovigilance team in August 2025 as a Drug Safety Expert. She holds a pharmacy degree and an MSc in Toxicology. Arda has gained extensive experience in pharmacovigilance, medical information and quality oversight within international companies. Her background enables her to approach drug safety from both a scientific and operational perspective, ensuring that regulatory requirements are translated into practical, workable processes.
At Medfiles, Arda is responsible for a range of pharmacovigilance activities, including global literature review, regulatory intelligence and vendor management. She is committed to delivering high-quality, reliable support that strengthens compliance and ensures patient safety across diverse product portfolios.
See also:
- What are the MAH’s post-authorisation pharmacovigilance responsibilities
- Additional risk minimisation measures (aRMMs) – from requirement to implementation
- Safety database is a fundamental element of case processing
- Outsourcing ICSR processing – benefits and considerations
- Global pharma company & Medfiles: Obtaining and maintaining marketing authorisations
References:
- 1 Fernandez Lynch H, Sachs RE, Lee S, Herder M, Ross JS, Ramachandran R. (2023) Extending the US Food and Drug Administration’s Postmarket Authorities. JAMA Health Forum. 2023 Jun 2;4(6):e231313. doi: 10.1001/jamahealthforum.2023.1313. PMID: 37294583.
- 2 Teixeira, T., Smith, R., & Müller, A. (2020). Expedited drug approvals and post-marketing safety actions: A transatlantic comparison. Clinical Therapeutics, 42(5), 789–800.
- 3 Fukuda, T., Tanaka, M., & Saito, Y. (2023). Comparative analysis of safety-related labeling changes in Japan, the US, and the EU. Regulatory Science Journal, 12(3), 145–158.
- 4 Kohama, M., Yamaguchi, T., & Nakamura, H. (2023). Impact of regulatory reforms on pharmacovigilance planning in Japan: A review of new drug approvals from 2016 to 2019. Drug Safety Insights, 18(2), 89–102.
- 5 Yasuoka, J., Nakamura, H., & Kohama, M. (2019). Global comparison of additional risk minimization activities: Regulatory and cultural perspectives. Therapeutic Risk Management, 15(4), 201–215.
