The regulatory approval process typically involves multiple stages:
Preclinical Studies: Initial testing in non-human subjects to gather safety and efficacy data. Clinical Trials: Multi-phase trials involving human participants to further assess the safety and effectiveness. Submission for Review: A comprehensive dossier is submitted to the regulatory body, including all preclinical and clinical data. Approval and Post-Market Surveillance: Once approved, the product is monitored for any long-term adverse effects.
