Gene therapies hold tremendous potential as revolutionary treatments for genetic disorders and inherited diseases, promising to address the underlying causes of conditions rather than just managing symptoms. As the field of gene therapy rapidly advances, establishing a robust and adaptive regulatory landscape becomes crucial to ensure patient safety, efficacy, and equitable access to these transformative therapies. This article provides an overview of the current regulatory landscape for gene therapies, covering key topics such as regulatory authorities and approval processes, safety considerations, pricing and accessibility challenges, ethical dilemmas, and the role of international collaboration and harmonization efforts. Moreover, the article discusses future prospects, including advancements in gene editing technologies, adaptive regulatory approaches, and regulatory considerations for complex diseases. Collaborative efforts among regulators, researchers, clinicians, patients, and industry stakeholders are essential to navigate the regulatory challenges and harness the full potential of gene therapies for the betterment of human health.
Gene therapies, Regulatory landscape, Genetic disorders, Regulatory authorities, Approval processes, Safety considerations, Pricing and accessibility, Ethical dilemmas, International collaboration, Gene editing technologies, Adaptive regulatory approaches, Complex diseases
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