##  [Brazil: ANVISA Leads Development of ICH M18 Guideline](/mandate/brazil-anvisa-leads-development-of-ich-m18-guideline) 

December 1, 2025

The Brazilian Health Regulatory Agency (ANVISA) announced the approval of a concept document that will guide the development of the ICH M18 guideline, under ANVISA’s leadership. This milestone reflects Brazil’s active and strategic role within the International Council for Harmonisation (ICH) and reinforces its contribution to the advancement of globally harmonized regulatory standards.

The concept document establishes the foundational principles and scope for the future ICH M18 guideline, supporting regulatory convergence and promoting consistent regulatory practices applicable to medicinal products across ICH regions.

**Key Highlights**

- ICH Leadership Role  
    ANVISA will lead the development of the ICH M18 guideline, reinforcing its position as a key contributor to international regulatory harmonization.
- Regulatory Convergence  
    The guideline aims to support alignment among regulatory authorities, promoting consistent interpretation and application of regulatory standards for medicinal products.
- Strategic Impact  
    Contributes to predictable regulatory pathways and improved efficiency for global development and regulatory strategies, while strengthening collaboration among ICH members and observers.
- Medicinal Products Scope  
    The future guideline will be applicable to regulatory processes involving medicinal products, supporting harmonized approaches across regions.

This development underscores Brazil’s commitment to international regulatory cooperation and the continuous evolution of global regulatory frameworks for medicinal products.



[Consult Now](/webform/consult%0A?url=https://preprod.freyrsolutions.com/markdownify/node/12351)



Source

[https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/aprovado-document…](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/aprovado-documento-norteador-para-elaboracao-do-guia-ich-m18-com-lideranca-da-anvisa)

 

 

Select Mandate HA

[ANVISA](/mandate-by-ha/anvisa)

 

Select Mandate Function

[Regulatory Affairs](/mandate-by-function/regulatory-affairs)