Pharmaceutical equivalence (German translation: pharmazeutische Äquivalenz) is a concept that refers to the comparison of two drugs. Two drugs are considered to have pharmaceutical equivalence if they contain the same active pharmaceutical ingredient or the same active substance in the same dosage and are available in the same or at least comparable dosage forms. It is an important concept in the field of pharmacy and medicine and can have important implications for patients, physicians and regulatory authorities.

Pharmaceutical equivalence is the prerequisite for two drugs to be assessed as bioequivalent (translation into German: bioäquivalent). Two drugs are bioequivalent if the bioavailability of the two drugs at the site of action is the same (within certain limits). Proof of bioequivalence to a reference listed drug is the prerequisite for a simplified authorization procedure for generic drugs (German: Generika).

Pharmaceutical equivalence is important because it ensures that one drug can be replaced by another, provided they are equivalent in all the abovementioned aspects. This can be important in terms of the drug’s availability and cost  to patients. However, the decision to substitute a drug should always be made with consideration for the patient’s individual needs and their condition.

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