What must a drug comply with to achieve therapeutic equivalence?

To achieve therapeutic equivalence, a drug must comply with good manufacturing practices (GMP). GMP is a system that ensures products are consistently produced and controlled according to quality standards. This compliance is essential in demonstrating that a drug is both safe and effective for its intended use.

Therapeutic equivalence is defined as the relationship between two pharmaceutical products that are pharmaceutically equivalent (they have the same active ingredient, dosage form, and strength) and produce the same therapeutic effect when given to patients under the conditions specified in the labeling. Compliance with GMP is crucial because it guarantees the standards for manufacturing, quality control, and proper labeling are met, ultimately leading to consistent drug identity, strength, quality, and purity.

Although market demand, manufacturer discretion, and patient satisfaction can have roles in the pharmaceutical industry, they do not directly relate to the criteria necessary for establishing therapeutic equivalence. Following good manufacturing practices is the core requirement ensuring the drug’s efficacy and safety align with the performance standards set for the equivalent products.