National Biosafety Management System: A Combined Framework Approach Based on 15 Key Elements.

Area of Science:

• Global Health Security
• Laboratory Systems Strengthening
• Biosafety and Biosecurity

Background:

• Infectious disease outbreaks highlight the need for strong biosafety and biosecurity in national laboratory systems.
• The Global Health Security Agenda identifies biosafety as essential for effectively managing infectious disease threats.
• Biosafety management systems (BMS) in low- and middle-income countries (LMICs) are often weak due to fragmented implementation, limited resources, and inadequate expertise.

Purpose of the Study:

• To propose a sustainable approach for developing robust biosafety management systems (BMS) in LMICs.
• To provide a conceptual framework with 15 key components for guiding BMS development.
• To offer practical tools, including a flexible planning matrix and resource identification, for implementing sustainable BMS.

Main Methods:

• Development of a conceptual framework based on extensive experience in LMICs.
• Incorporation of 15 critical components for a holistic BMS approach.
• Inclusion of a flexible planning matrix and resource identification for sustainable expertise development.

Main Results:

• A comprehensive conceptual framework for building strong, self-sustaining BMS in LMICs.
• Guidance for implementers, national laboratory leaders, and global health security experts.
• Adaptable planning tools and resource strategies to overcome common implementation barriers.

Conclusions:

• A structured, holistic approach is necessary for effective BMS development in LMICs.
• The proposed framework and tools can enhance national laboratory resilience against infectious disease threats.
• Sustainable technical expertise and political will are critical for long-term biosafety success.