EVALUATING THE EFFECTIVENESS OF RISK-BASED APPROACHES IN STREAMLINING THE REGULATORY APPROVAL PROCESS FOR NOVEL THERAPIES
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Keywords
Risk-based approaches, regulatory approval, novel therapies, safety outcomes, expedited approval
Abstract
The study evaluates the effectiveness of risk-based approaches in streamlining the regulatory approval process for novel therapies. Utilizing a mixed-method research design, the study combines quantitative analysis of approval times, safety, and efficacy outcomes with qualitative insights from case studies and expert interviews. Data were sourced from major regulatory agencies, including the FDA and EMA, and included therapies approved through traditional and risk-based pathways such as accelerated approval mechanisms, adaptive pathways, and breakthrough therapy designations. Key findings indicate that risk-based approaches significantly reduce approval times, with therapies approved via these methods taking, on average, 18 months compared to 36 months for traditional approaches. Safety and efficacy outcomes for therapies approved through risk-based frameworks were comparable to those approved through traditional pathways, demonstrating that expedited approval does not compromise patient safety or therapeutic effectiveness. Stakeholder satisfaction surveys revealed higher satisfaction levels among pharmaceutical companies, healthcare providers, and regulatory agencies involved in risk-based approvals.
The study's implications suggest that regulatory bodies should continue to develop and implement risk-based frameworks to enhance efficiency while maintaining safety standards. The pharmaceutical industry can benefit from reduced development times and earlier market entry, leading to cost savings and improved returns on investment. Strengths of the study include its comprehensive mixed-method design and diverse data sources, while limitations point to the need for larger sample sizes and long-term follow-up studies.
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Sri Sai Subramanyam Challa
Independent Researcher,USA.