What is the Process for Obtaining Regulatory Approval?
The process for obtaining regulatory approval generally involves several stages:
Preclinical Research: Initial studies are conducted in laboratories and on animal models to evaluate the potential efficacy and safety of a new treatment. Clinical Trials: If preclinical results are promising, the treatment moves to clinical trials, which are conducted in phases:
Phase I: Small-scale trials to assess safety and dosage. Phase II: Larger trials to assess efficacy and side effects. Phase III: Large-scale trials to confirm efficacy, monitor side effects, and compare with standard treatments.
Regulatory Submission: After successful clinical trials, a comprehensive dossier is submitted to regulatory agencies for review. Review and Approval: Regulatory agencies review the submitted data and may request further information before granting approval.
