Regulatory Science_OLD

Research Interests

Capacity Building, Regulatory Science, Biosafety, Biosecurity, Emerging Biotechnologies, Governance.

Description of Research

The effective and safe use of biotechnology requires strong policies, regulations and processes to support national decision-makers. The ICGEB Regulatory Science Group helps countries build and strengthen regulatory capacities through an integrated, tailored approach.

The Group focuses on improving regulatory effectiveness in a rapidly changing biotechnology landscape. Over the past decade, it has strengthened institutional capacities in sub-Saharan Africa, Central America and the Caribbean, supporting governments in regulating biotechnology products in line with their policy goals.

The emergence of new tools – such as gene drives, genome editing and RNAi – has expanded the range of applications and increased requests for assistance. Beyond its earlier work on genetically modified organisms (GMOs), the Group now addresses broader biotechnology regulation, including gene-drive and synthetic biology products and biotechnologies used in Public Health.

International donors and philanthropic foundations fund the activities. Support includes administrative and technical tools for National Competent Authorities (NCAs), expert committees, and the regulated community. Collaboration with government experts ensures that procedures are adapted to national frameworks and comply with international standards, are immediately applicable and delivered in ways that build skills and foster peer networking. This approach creates solid regional and international networks, strengthening regulatory expertise, autonomy and preparedness for emerging challenges. The long-term goal is to establish resilient, non-fragmented systems that function independently of human resource turnover.

In addition to capacity building, the Group contributes to knowledge synthesis and policy engagement. Its members publish in peer-reviewed journals, prepare technical reports for policymakers, and synthesise knowledge in areas such as gene drives, genome editing and biosecurity. They contribute to global discussions (prioritising those held in important international fora), including emerging issues such as synthetic biology, AI-biosecurity interactions, and the potential risks of mirror life. This dual role – building capacity while shaping global debates – reinforces the Group’s identity as a trusted source of regulatory science expertise.

The Group has also developed a free-to-end-user portfolio of eLearning modules covering various aspects of biosafety, biosecurity and public health, offered to regulatory authorities in sub-Saharan Africa and available to research institutions and multi-disciplinary projects across ICGEB Member States.

The Group’s work contributes to the UN SDGs through South–South and triangular (South–North–South) cooperation. Supporting personal and institutional capacity building, it empowers regulatory offices and the regulated community in the Global South. Strong, autonomous regulatory systems enable safer and healthier food and products with fewer resources, while reducing pressure on ecosystems. They also facilitate value-added trade in biotechnology products.

International Technical and Policy Fora

Below is a list of examples of recent fora in which Group members have been participating.

Recent Projects

Below is a list of examples of recent projects which the Group has been implementing

Online Resources

eLearning Showcase
A portfolio of curriculum-based modules encompassing the biosafety of genetically modified organisms and related matters in biosecurity, public health, natural resource management, biocontrol and bioremediation.

Recent Publications

Moronta-Barrios F, Freemont P, Kiattisewee C, Lindner A, Novak B, Redford K, Seah A, 2025.Nature Conservation in the Age of Bioengineering. Rice University.

Molla KA, Moronta-Barrios F, Karembu M, de Haro L, Jannah R, 2025. The Spirit of Asilomar: Lessons for the next era of biotechnology governance. Trends in Biotechnology.

Rabuma T, Moronta-Barrios F, Craig W, 2024.Navigating biosafety regulatory frameworks for genetic engineering in Africa: a focus on genome editing and gene drive technologies. Frontiers in Bioengineering and Biotechnology 12:1483279.

Marcello A, Hodzic M, Susnjar U, Craig W, 2023. PA-748 Platform for efficient health emergency response of community diagnostic and surveillance laboratories. BMJ Global Health.

Craig W, Sara R, Moronta-Barrios F, Araya-Quesada M, McLoughlin AG, Mandivenyi W, Garforth K, Cooper HD, 2022. Synthetic Biology. CBD Technical Series No. 100. Montreal, Canada.

Anbumozhi V, Babu S, Bollino CA, Craig W, Kulandivelu P, Moronta-Barrios F, Yamaji E, 2021. Enhancing Food Supply Chain Resilience Through the Utilisation of Digital and Sequence Information Technologies. Task Force 4. Digital Transformation. G20 Think20 Italy.

Arndt C, Chambers J, Zambrano P, Alahmdi MI, Alatawi A, Benfica R, Edward MG, Gatehouse AMR, Moronta-Barrios F, Ahmed A, 2020. Embracing Innovation to Meet Food Systems Challenges. Task Force 10. Sustainable Energy, Water, and Food Systems. G20 Insights

Arpaia S, Christiaens O, Giddings K, Jones H, Mezzetti B, Moronta-Barrios F, Perry J, Sweet J, Taning C, Smagghe G & Dietz-Pfeilstetter A, 2020. Biosafety of GM crop plants expressing dsRNA: Data requirements and EU regulatory considerations. Frontiers in Plant Science, 11: 940-952

Devos Y, Craig W, Devlin RH, Ippolito A, Leggatt RA, Romeis J, Shaw R, Svendsen C & Topping CJ, 2019. Using problem formulation for fit-for-purpose pre-market environmental risk assessments of regulated stressors. EFSA Journal 17(S1): e170708.

Seyran E, & Craig W, 2018. New Breeding Techniques and Their Possible Regulation. AgBioForum, 21(1): 1-12

Ndolo D, Wach M, Rüdelsheim P & Craig W, 2018. A Curriculum-Based Approach to Teaching Biosafety Through eLearning. Frontiers in Bioengineering and Biotechnology, 6: 42-49

Rosado A, Craig W, 2017. Biosafety regulatory systems overseeing the use of genetically modified organisms in the Latin America and Caribbean region. AgBioForum, 20(2): 120-132

Group Leader

Wendy Craig
ICGEB Trieste, Italy

Group Members

Francesca Farolfi, Senior Programme Assistant
Felix Moronta Barrios, Senior Programme Assistant
Muris Hodzic, Project Assistant

For more information:
Regulatory Science Group
Tel: +39-040-3757320
Email: [email protected]