The approval process generally involves several key stages:
Preclinical Research: Initial studies are conducted in laboratories and on animals to gather preliminary data on safety and efficacy. Clinical Trials: Human trials are conducted in multiple phases. Phase I focuses on safety, Phase II on efficacy and side effects, and Phase III compares the new treatment to existing standards. Submission of Data: After successful clinical trials, a comprehensive dossier of all research findings is submitted to the regulatory body. Review and Approval: The regulatory body reviews the data, often involving a panel of experts, before granting approval.
