The regulatory approval process generally involves several key steps, including:
1. Preclinical Studies - Initial laboratory and animal studies to assess the safety and biological activity of a product. 2. Clinical Trials - Human studies conducted in phases (Phase I, II, III) to evaluate the safety, efficacy, and optimal dosing. 3. Submission of a Regulatory Application - Compilation of all data and findings into a comprehensive application submitted to the regulatory body. 4. Review and Evaluation - Detailed assessment by the regulatory body, which may involve advisory committees and public consultations. 5. Post-Marketing Surveillance - Ongoing monitoring of the product's safety and effectiveness after approval.
