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Updated: May 12, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

Microbicides from a regulatory perspective.

Alan B Stone¹, Polly F Harrison, Manjula Lusti-Narasimhan

¹aMedical Scientific Advisory Services Limited, London, UK bAVAC (Global Advocacy for HIV Prevention), New York, New York, USA cDepartment of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.

AIDS (London, England)

|April 25, 2013

Summary

Regulatory guidance for microbicide development is clearer thanks to international consultations. These efforts advance the development of topical microbicides for preventing HIV and other sexually transmitted infections (STIs).

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Published on: November 5, 2016

Area of Science:

Public Health
Infectious Diseases
Regulatory Science

Background:

Microbicides are crucial for HIV prevention strategies.
Developing and licensing microbicides requires clear regulatory pathways.
International collaboration is essential for advancing microbicide research.

Purpose of the Study:

To consolidate and present regulatory guidance for microbicide development and licensure.
To serve as a reference for researchers, sponsors, regulators, and funders.
To address the evolving landscape of HIV prevention.

Main Methods:

Convened a series of international technical consultations over a decade.
Engaged diverse global experts in microbicide development and testing.
Synthesized consultation outcomes within the context of HIV prevention.

Main Results:

Clarified the scientific foundation for regulatory guidance on microbicide development.
Established a clearer path for microbicide licensure.
Facilitated a better understanding of regulatory requirements.

Conclusions:

WHO-organized consultations significantly broadened regulatory perspectives.
Enhanced understanding of topical microbicide development and testing for HIV and STI prevention.
Advanced the regulatory science underpinning microbicide licensure.