Research Interests
The effective and safe use of biotechnologies requires a broad portfolio of policies, regulations, and processes to support national decision-makers. By applying an integrated, synergistic, and tailored approach, the ICGEB Regulatory Science Group assists countries to create and enhance national capacities in the regulation of biotechnology and its products.
Description
The focus of the Group is primarily the improvement of capacities to ensure regulatory effectiveness in a changing landscape of evolving biotechnologies and human resource mobilisation. For over 10 years, the Group has strengthened the institutional capacities of governments in sub-Saharan Africa, Central America and the Caribbean to regulate the products of biotechnologies in alignment with their policy objectives.
The emergence of new biotechnologies, especially gene drives, genome editing and RNAi technologies, which result in a broader range of applications and which, by extension, help governments to attain a broader range of policy goals, has also resulted in increased requests for support. In addition to its previous work concerning the regulation of genetically modified organisms (GMOs), the Group is expanding the type of assistance it provides; to include, for example, the exploration and refinement of the regulatory arenas that cover non-GMO biotechnology products.
The activities of the Group are financially sustained through significant contributions from eminent international donors and philanthropic foundations, and provide a range of administrative and technical tools and approaches to help improve the effectiveness of National Competent Authorities (NCAs) and their technical committees. It does so in partnership with the concerned government officials and experts, such that the resultant procedures and processes are not only tailored to the national regulatory framework and are immediately applicable, but is done so in a collaborative fashion to help guide and improve the skills of regulatory officials and encourage networking with their regional and international peers. In this way, they are empowered to address their needs more autonomously, whilst becoming more aware of regulatory challenges arising elsewhere and thus can increase their preparedness. The ultimate goal is to develop robust, non-fragmented regulatory mechanisms that are independent of human resource fluctuations.
The Group has also developed a portfolio of eLearning biosafety modules that is being offered freely to regulatory authorities in sub-Saharan Africa (https://showcase-icgeb.elearning.it/index.html), and is also available to similar entities, research institutions and multi-disciplinary projects in and beyond ICGEB Member States.
ICGEB Regulatory Science Group and UN Sustainable Development Goals
The Group’s activities support and organise triangular cooperation to energise and strengthen biotechnology regulatory offices in the Global South. A strategic approach for personal and institutional capacity building has been employed, such as South-South partnerships, triangular cooperation (South-North-South), and critical alliances. The outcome of autonomous, robust and structured regulation is the availability of more healthier and safer food and products from fewer resources while reducing pressure on natural ecosystems, as well as the support of value-added commodity trade to support sustainable development. Hence, SDGs 2, 3, 9, 12, 15, and 17 are guiding these activities.
Recent Projects
 | Monitoring Gene Drives: new website for gene drive research Providing research updates through a free, multilingual living literature review on gene drives |
 | EXPANDIA: Expanding Access to Sustainable Diagnostics in Africa Strengthening lab networks in Africa for sustainable diagnosis of (re)emerging diseases |
 | COVID-19+: Community Access Diagnostics laboratory networks Diagnostic and surveillance empowerment of community laboratories in Africa |
 | Trainers and Facilitators for IUCN Policy on Synthetic Biology for Nature Conservation Development Process Supported the development of the draft IUCN Policy on Synthetic Biology in relation to nature conservation |
 | Development of the outline for the additional voluntary guidance materials to support the risk assessment of living modified organisms containing engineered gene drives Developed a detailed outline to inform voluntary guidance materials for the risk assessment of gene drive organisms |
International Technical and Policy Fora
| Expert Roundtable on Mirror Life (UN Secretary-General’s Scientific Advisory Board) – Online, November 2025. |
| Roundtable Assessing Quantitative Needs in Synthetic Biology and AI (OECD) – Online, November 2025. |
| Science-policy briefings in the run-up to COP30: Synthetic Biology for Low-Carbon Fuels and Industrial Materials (UNCPR-GSPI) – Geneva, October 2025. |
| The Paris Meeting on the Risks of Mirror Life (Mirror Biology Dialogues Fund) – Institut Pasteur, Paris, France, June 2025. |
| Strategic Foresight on Dual-use Research at the One Health Intersection (WHO) – Online, April 2025. |
| Spirit of Asilomar and the Future of Biotechnology Conference (Stanford University, Rice university, Science History Institute) – California, USA, February 2025 |
| Synthetic Biology in Relation to Nature Conservation (IUCN) – Kenya, Thailand, Spain, Guatemala, Switzerland, October 2023 to September 2024. |
| Meeting of the Science Academies of the G7 Countries (Accademia dei Lincei) – Rome, Italy, April 2024. |
| Foresight Sensemaking Workshop (UNEP-ISC) – Paris, France, March 2024. |
| Biorisks, Biosecurity and Biological Disarmament Conference (WHO-UNIDIR-UNODA) – Geneva, Switzerland, July 2023. |
Previous Projects
| ICGEB BCH III Project |
| Biosafety Capacity Building in sub-Saharan Africa |
| Assisting the Caribbean Regional Biosafety project |
| GRACE: GMO Risk Assessment and Communication of Evidence |
| Italian BCH: Biosafety Clearing House |
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
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.
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
Racovita M, Obonyo DN, Craig W, Ripandelli D, 2015. What are the non-food impacts of GM crop cultivation on farmers’ health? Environmental Evidence 4:17
Obonyo DN, Racovita M, Ripandelli D, Craig W, 2014.Biosafety issues in food and agricultural systems in Africa
Racovita M, Obonyo DN, Craig W, Ripandelli D, 2014. What are the non-food impacts of GM crop cultivation on farmers’ health? A systematic review protocol. Environmental Evidence 3(1)
For more information:
Regulatory Science Group
Email: [email protected]
Group Leader
Wendy Craig
ICGEB Trieste, Italy
Email: [email protected]
Group Members
Francesca Farolfi, Senior Programme Assistant
Felix Moronta Barrios, Senior Programme Assistant
Muris Hodzic, Project Assistant
