These guidelines provide a summary of commonly used techniques in genome editing, highlight biosafety legal and institutional framework including processes that are followed in reviewing applications for use of genetically modified organisms in Malawi. A step-by-step procedure for determining which genome-edited products are regulated as GMOs and those that are exempted is also provided.

The main objective of these Guidelines is to provide technical guidance to applicants, regulators, reviewers and stakeholders on the criteria for determining the regulatory options of genome-editing processes and products that should, or should not be regulated under the Biosafety Act of 2002 and its Regulations.
These guidelines shall apply to organisms/or derived products whose genome has been altered using genome editing techniques resulting in either a GMO or organisms that are not distinguishable from those developed from conventional breeding or natural selection. The guidelines shall provide clarity on whether a specific genome product should be regulated or excluded from the current biosafety laws. Users of these guidelines may include: applicants who submit an application to the NBRC for approval for a product that has been altered using genome editing techniques; regulators and reviewers who have to determine which genome editing processes and derived products are subject to the Biosafety Act and Biosafety Regulations; and, other relevant stakeholders. Click here for more information