What is the main purpose of the Drug Approval Procedure?

The main purpose of the Drug Approval Procedure is to ensure the safety and efficacy of drugs before they are approved for the market. This process involves rigorous evaluation by regulatory bodies, such as the U.S. Food and Drug Administration (FDA), which examines clinical trial data to determine whether a drug is effective for its intended use and whether it poses an acceptable level of risk to patients.

The thorough review process helps protect public health by making certain that medications meet established standards for quality and do not pose unexpected dangers when used as directed. The focus on safety ensures that harmful side effects or adverse reactions are identified and addressed prior to a drug being made available to consumers. Efficacy confirms that the drug achieves its intended therapeutic effect, thereby ensuring it will provide a benefit to those who use it.

Other aspects of drug regulation, such as pricing and advertising claims, are important but are not the primary focus of the Drug Approval Procedure. Similarly, monitoring post-market drug performance is crucial for evaluating ongoing safety and effectiveness but occurs after a drug has already been approved and is on the market.