Which factor typically influences the decision for a drug's approval?

The decision for a drug's approval is primarily influenced by the requirement for substantial evidence of safety and efficacy. Regulatory agencies, such as the FDA in the United States, mandate that any new drug must demonstrate that it is both safe for use and effective for its intended purpose through rigorous clinical trials. This evidence is crucial because it ensures that the drug will perform its intended function without causing undue harm to patients.

Regulatory bodies assess clinical trial data to evaluate outcomes such as adverse events, side effects, and overall therapeutic benefits. This thorough review process is designed to protect public health and ensure that only drugs that meet high scientific and medical standards are approved for market. Consequently, without substantial evidence proving safety and efficacy, a drug cannot be approved, regardless of other factors like market demands, competition, or business relationships.

Other factors do play a role in the broader context of drug development and commercialization, but they do not directly influence the regulatory approval process in the same way that safety and efficacy do.