The Guidelines provides a regulatory framework for determining whether genome‑edited organisms and products fall within the scope of Ghana’s biosafety legislation, taking into account international obligations under the Cartagena Protocol on Biosafety. The Guidelines explain the scientific basis of genome editing techniques, and related methods, and clarify that not all genome‑edited products are considered genetically modified organisms (GMOs). Only genome‑edited organisms that contain foreign genes or result in a novel combination of genetic material are subject to regulation under the Biosafety Act. The Guidelines outline the scope, objectives and application process, including mandatory pre‑submission consultations with the NBA to determine regulatory status on a case‑by‑case basis. They identify categories of genome editing techniques and products that are either regulated or exempted. Procedural steps, regulatory decision criteria, sanctions for non‑compliance, and review mechanisms are provided to ensure science‑based biosafety oversight. The Guidelines apply to genome editing activities involving plants, animals and microorganisms, covering contained use, confined field trials, environmental release, marketing, import, export and transit, while excluding genome‑edited pharmaceuticals regulated under other enactments.
غانا · 2023-10-30