ESTABLISHING A NATIONAL REGULATORY POLICY AND FRAMEWORK FOR THERAPEUTIC USE OF CELL AND TISSUE THERAPIES IN SULTANATE OF OMAN.

Background & Aim The field of regenerative medicine including cellular immunotherapies is witnessing a remarkable growth trajectory worldwide. However, most of these advanced therapies remain in the experimental phase owing, among other reasons, to insufficient evidence of their safety profile and clinical efficacy. Moreover, there is the global proliferation of unproven cell and tissue based industry that prematurely commercialize unapproved cell and tissue based therapies with unknown safety and efficacy profiles. Such businesses target and nurture in areas that lack regulatory policies to control their activities. Sultanate of Oman, like other countries in the middle east region are becoming an attractive hub for such businesses due to the lack of regulatory policies and practices to control unproven interventions. The aim of this project was to establish a national regulatory policy and framework for the clinical use of cell and tissue therapies in Sultanate of Oman. Methods, Results & Conclusion: Method The regulatory policy is focused in creating a clear pathway for, interventions and marketing of human cellular and tissue based therapies (HCT/Ps) based on internationally benched marked regulations and regulatory authorities recommendations such as FDA, EMA and WHO. Results The regulatory policy consisted of 100 articles distributed in ten chapters and is supplemented by nine annexes. The policy was tailored to address the following aspects: Regulatory classification of HCT/Ps, Establishing a committee of advanced therapies, Defining: Permissible human cells and tissue therapies, Therapeutic use of stem cells, progenitor cells and their derivatives, Introducing compassionate use access scheme for advanced therapies, Regulation of advertising and promotion , General obligations of health sector authorities, General obligations of cellular and tissue therapy establishments and penalties and sanctions section. Conclusion This project represent an essential step to develop and harmonize the regulatory system in Oman to meet internationally bench marked regulatory systems. Implementation of this regulatory policy will guide more appropriate oversight for the wide spectrum of cellular and tissue-based products that are now used/marketed or envisioned for the future. Moreover it will ensure protection of the public and will increase public confidence in these new technologies while, promoting evidenced-based innovation to go forward. The field of regenerative medicine including cellular immunotherapies is witnessing a remarkable growth trajectory worldwide. However, most of these advanced therapies remain in the experimental phase owing, among other reasons, to insufficient evidence of their safety profile and clinical efficacy. Moreover, there is the global proliferation of unproven cell and tissue based industry that prematurely commercialize unapproved cell and tissue based therapies with unknown safety and efficacy profiles. Such businesses target and nurture in areas that lack regulatory policies to control their activities. Sultanate of Oman, like other countries in the middle east region are becoming an attractive hub for such businesses due to the lack of regulatory policies and practices to control unproven interventions. The aim of this project was to establish a national regulatory policy and framework for the clinical use of cell and tissue therapies in Sultanate of Oman. The regulatory policy is focused in creating a clear pathway for, interventions and marketing of human cellular and tissue based therapies (HCT/Ps) based on internationally benched marked regulations and regulatory authorities recommendations such as FDA, EMA and WHO.