What is the primary purpose of a clinical trial submission to a regulatory authority?

The primary purpose of a clinical trial submission to a regulatory authority is to demonstrate the safety and efficacy of a new product. This process is essential for obtaining regulatory approval for a drug or treatment before it can be marketed to the public. Regulatory authorities, such as the FDA or EMA, require comprehensive clinical data to assess whether a new drug is both safe for human use and effective for its intended purpose. This information comes from carefully designed clinical trials that provide evidence supporting the claims made by the sponsor.

While seeking approval for drug marketing is a related activity, this step is contingent upon proving the drug's safety and efficacy through the clinical trial data. Establishing patent rights and gathering sales data, while important aspects of the pharmaceutical development and commercialization process, are not the primary focus of clinical trial submissions. The main goal remains centered on demonstrating that the drug performs as intended without posing undue risk to users.