In the development of pharmaceuticals, quasi-drugs, medical devices, and regenerative medicine products (hereinafter referred to as "medical products"), alternative methods to animal testing have been explored based on the ethical principle of the 3Rs (Reduction, Refinement, and Replacement). In recent years, a comprehensive concept called "New Approach Methodologies (NAMs)" has been advocated. This approach goes beyond simply replacing animal testing and aims to improve the quality and success rate of scientific decision-making in medical product development by enhancing extrapolation to human and the predictivity.
NAMs encompass a variety of new approaches that utilize innovative science and technology, including in chemico, in vitro (e.g., organoids, Microphysiological Systems (MPS)), and in silico methods. By increasing the predictability of human safety, efficacy, and pharmacokinetics, NAMs are expected to reduce reliance on animal testing and meet both humanitarian and societal demands.
PMDA's Initiatives
The PMDA anticipates that the utilization of NAMs in the development of medical products etc. will improve the predictability of human safety, efficacy, and pharmacokinetics etc. This will contribute to the further promotion of medical product development in Japan and the advancement of the 3Rs. On the other hand, we recognize that there are challenges to the utilization of NAMs in medical product development, including their acceptance by regulatory authorities.
To address these challenges, the PMDA will promote regulatory science related to NAMs through the following initiatives, in close cooperation, coordination, and discussion with relevant domestic and international stakeholders including regulatory authorities.
Establishment of the NAMs Working Group
The PMDA has established an internal NAMs Working Group to discuss various issues related to NAMs. This cross-functional group consists of members from the New Drug Review Divisions, Regenerative Medicine Products Review Department, Vaccine and Blood Products Review Department, OTC/Quasi-drug Review Department, Office of Manufacturing/Quality and Compliance, and Medical Device Review Divisions, and will proceed with discussions on various challenges concerning NAMs.
Collaboration with Domestic Stakeholders
To promote the utilization of NAMs for enhancing the predictability of human safety, efficacy, and pharmacokinetics etc., the PMDA will collaborate with the National Institute of Health Sciences (NIHS) / Japanese Center for the Validation of Alternative Methods (JaCVAM)¹, industry, academia, and other stakeholders to explore the potential applications of NAMs.
Collaboration with Oversea Regulatory Authorities
The PMDA believes it is crucial for regulatory authorities to align their approaches from an international harmonization perspective. The PMDA will collaborate with overseas regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency to actively discuss the scientific evaluation of NAMs and the impact of their utilization on existing frameworks in international forums such as ICH², ICCR³, and ISO⁴, to ensure international consistency.
PMDA's Activities
The PMDA will disseminate information on its NAMs-related activities through this website.
Activities:
Domestic Public Research Activities
Major Ongoing International Activities
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- International Cooperation on Cosmetics Regulation (ICCR)
https://www.iccr-cosmetics.org/
- International Medicines Regulators' Working Group on 3Rs (IMRWG3Rs)
- Complement Animal Research in Experimentation (Complement-ARIE) New Approach Methodologies (NAMs) Validation Qualification Network (VQN)
https://commonfund.nih.gov/complementarie/vqn
- ISO/TC 194 Biological and clinical evaluation of medical devices
https://www.iso.org/committee/54508.html
Published materials
Fiscal Year 2025
MPS World Summit 2025, Brussels, Belgium, June 2025
FDA-NIH Workshop: Reducing Animal Testing, Silver Spring, USA (Web presentation), July 2025
- Trends in NAMs as Drug Development Tools and Future Prospects in Japan [3.82MB] (available in Japanese only)
The 65th Annual Meeting of the Japanese Teratology Society, Mie, July 2025
Early Consideration
To be posted as soon as it is published.
Related regulations
- Guidance on Safety Evaluation of Cosmetics and Quasi-Pharmaceutical Products (Alternative Methods to Animal Testing, etc.)
www.pmda.go.jp/review-services/drug-reviews/about-reviews/q-drugs/0002.html (Link to Japanese site)
- ICH Guidelines
Multidisciplinary Guidelines (ICH M3(R2), M7(R2) Guidelines)
www.pmda.go.jp/int-activities/int-harmony/ich/0034.html (Link to Japanese site)
Safety Guidelines (Non-clinical Guidelines)
www.pmda.go.jp/int-activities/int-harmony/ich/0069.html (Link to Japanese site)
- Notifications related to the Biological Safety Evaluation of Medical Devices
https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0055.html (Link to Japanese site)
Upcoming Events
- Announcement of PMDA Symposium: "Toward Prompt Access to Pharmaceuticals and Quasi-Pharmaceutical Products Needed by the Public - Thinking About the Future of NAMs"
Date and Time : Friday, October 31, 2025, 13:00 - 17:00 (JST)
Format : Webinar
Details : https://www.pmda.go.jp/review-services/symposia/0189.html (Link to Japanese site)
References
1) Japanese Center for Validation of Alternative Methods (JaCVAM)https://www.jacvam.jp/en/index.html
2) International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 3) International Cooperation on Cosmetics Regulation 4) International Organization for Standardization