The COVID-19 pandemic has once again underscored the significance of laboratory biosafety and biosecurity management. In the post-pandemic era, it has also driven the rapid development of domestic biotechnology, leading to an increasing demand for institutions to set up high-containment laboratories. In order to enhance the autonomous management capability of institutions, Taiwan CDC amended the “Regulations Governing Management of Infectious Biological Materials” on December 15, 2021. The entities that possess, store, or use pathogens and toxins in Risk Groups (RG) 2 to RG4 shall assign a biosafety officer (BSO) to supervise biosafety management affairs, such as conducting annual internal laboratory audits and supervising emergency response drills in laboratories. Furthermore, Taiwan CDC formulated the “Operation Guideline for Certification and Management of Training Institutions for Biosafety Management Personnel” with the purpose of vigorously promoting the training, certification, and accreditation systems for biosafety management personnel, thereby cultivating a solid foundation of biosafety management talents.
By December 2024, 613 entities had set up biosafety management units and reported to Taiwan CDC, including 24 government agencies, 168 medical institutions, 61 academic research institutions, and 360 other groups. Among them, 488 entities established biosafety committees and 125 entities had a designated BSO.
Taiwan CDC has continuously promoted laboratory biosafety management policies through regulatory norms, educational training, on-site guidance, and inspections. These efforts aim to strengthen laboratory biosafety and biosecurity management.

Accomplishments
1.Biosafety Inspections of Microbiological and Biomedical Laboratories
Since 2006, Taiwan CDC has routinely inspected entities with high-containment laboratories or facilities that store or use RG3 pathogens. In 2024, a total of 31 highcontainment laboratories, TB containment laboratories and RG3 pathogen storage facilities completed biosafety inspections. Thirty of the 31 inspected laboratories passed the inspections or completed an improvement process, with a pass rate of 96.8%. Additionally, 12 laboratories and storage facilities that use select agents and toxins completed biosafety inspections, with a pass rate of 100%. Furthermore, Taiwan CDC supervised laboratory inspections of 160 biosafety level -2 (BSL-2) microbiology laboratories carried out by local competent authorities.
2.Laboratory Biosafety Education and Training
In 2024, Taiwan CDC conducted a professional development seminar for high-containment laboratories personnel and biosafety and biosecurity training course for highcontainment and TB-containment laboratories. In addition, 8 on-line courses on laboratory biosafety were developed and published on the e-learning website.
3.Development of Assessment Tools for the Knowledge and Skills of the BSO
To enhance biosafety and biosecurity management work in domestic laboratories, Taiwan CDC launched the “Pilot Assessment Operation for Knowledge and Skills of BSO” on August 14, 2024 and conducted four briefing sessions for entities with a total attendance of 829 laboratory staff members. Meanwhile, the results from the 510 entities were collected for further in-depth investigations and analyses of the level and integrity of the knowledge and skills of the current BSO.

1. Refine and update laboratory biosafety and biosecurity management policies, standards, and  guidelines in a timely manner by referencing regulations from WHO and leading countries to align with international trends.
2. Continue to conduct the annual biosafety inspections of high-containment laboratories, laboratories, and storage facilities that use select agents and toxins, and BSL-2 laboratories to reduce laboratory-acquired infections.
3. Promote the certification process of BSO by participating in the training of biosafety management personnel to maintain the requisite professional knowledge and capabilities.
4. Continue to organize biosafety and biosecurity education training courses or seminars, and conduct assessments of professional competence and suitability for BSO to enable laboratories to enhance self-management abilities.
5. Continue to improve the function and efficiency of the Laboratory Biosafety Management Information System, and strengthen monitoring, reporting, and related statistics on the use of RG2 to RG4 pathogens and toxins.