Interactive Infographic

Global NAMs Regulations

How different countries and regions are adopting New Approach Methodologies in drug development and testing

Advanced Adoption
Actively Progressing
Developing Framework
Limited Progress
North America South America Europe Asia Oceania
US
United States (FDA)
CA
Canada (HC)
EU
European Union (EMA)
UK
United Kingdom (MHRA)
CH
Switzerland (Swissmedic)
JP
Japan (PMDA)
CN
China (NMPA)
KR
South Korea (MFDS)
AU
Australia (TGA)
BR
Brazil (ANVISA)
IN
India (CDSCO)
SG
Singapore (HSA)
🇺🇸

United States

FDA - Food & Drug Administration
Advanced Adoption
  • FDA Modernization Act 2.0 (2022) removed animal testing mandate
  • FDA Modernization Act 3.0 (2023) extended to cosmetics
  • ISTAND program provides NAMs validation guidance
  • Active acceptance of organ-chip and organoid data
Key Milestone
First drug approved using organ-chip data (2022)
🇪🇺

European Union

EMA - European Medicines Agency
Advanced Adoption
  • EU cosmetics animal testing ban since 2013
  • REACH regulation promotes alternative methods
  • Innovation Task Force reviews NAMs submissions
  • Strong investment in 3Rs (Replace, Reduce, Refine)
Key Milestone
Complete cosmetics testing ban achieved (2013)
🇬🇧

United Kingdom

MHRA - Medicines & Healthcare products
Advanced Adoption
  • NC3Rs leads global 3Rs research and funding
  • Innovative Licensing and Access Pathway (ILAP)
  • Strong regulatory sandbox for NAMs testing
  • Post-Brexit flexibility for faster adoption
Key Milestone
NC3Rs funded 700+ alternative method projects
🇯🇵

Japan

PMDA - Pharmaceuticals & Medical Devices
Actively Progressing
  • JaCVAM validates alternative test methods
  • AMED funding for microphysiological systems
  • Increasing acceptance of in silico methods
  • Strong industry investment in organ-on-chip
Key Milestone
National MPS consortium established (2020)
🇸🇬

Singapore

HSA - Health Sciences Authority
Advanced Adoption
  • A*STAR leads NAMs research in Asia
  • Regulatory sandbox for innovative testing
  • Strong biotech ecosystem for NAMs companies
  • Fast-track pathways for NAMs-based submissions
Key Milestone
Asia's first organ-chip regulatory guidance (2023)
🇨🇳

China

NMPA - National Medical Products Admin
Developing Framework
  • Increasing domestic NAMs research investment
  • Gradual acceptance of in vitro alternatives
  • Animal testing still required for most drugs
  • Growing organ-on-chip manufacturing sector
Key Milestone
First NAMs guidance document released (2024)

Regulatory Framework Comparison

Region Animal Testing Mandate NAMs Accepted Organ-Chip Data Cosmetics Ban In Silico Methods
USA (FDA) Removed (2022) Yes Accepted Banned (2023) Accepted
EU (EMA) Reduced Yes Accepted Banned (2013) Accepted
UK (MHRA) Reduced Yes Accepted Banned Accepted
Japan (PMDA) Required Partial Case-by-case Not banned Accepted
Singapore (HSA) Optional Yes Accepted Banned Accepted
China (NMPA) Required Limited Pilot programs Not banned Limited
Brazil (ANVISA) Required Limited Not accepted Not banned Limited
India (CDSCO) Required Developing Not accepted Partial ban Developing

Global NAMs Adoption Timeline

2013
European Union
Complete ban on animal testing for cosmetics and cosmetic ingredients
2016
United States
21st Century Cures Act encourages FDA to consider alternatives
2020
Japan
National MPS consortium launched for organ-chip development
2022
United States
FDA Modernization Act 2.0 ends 84-year animal testing mandate
2023
Singapore
First Asian regulatory guidance for organ-on-chip data
2024
Global
ICH guidelines updated to include NAMs validation standards

Explore More Regulatory Information

Dive deeper into specific regulatory frameworks and how they affect drug development

Regulatory Hub US Timeline NAMs Companies