Reference listed drug: A drug (British English: medicinal product) that is used as a reference for the assessment of bioequivalence or therapeutic equivalence, quality, efficacy and safety of a generic drug or a biosimilar in the course of a simplified market authorization procedure.

The reference listed drug (British English: reference medicine, German translation: Referenzarzneimittel) for the marketing authorization of a generic drug or a biosimilar is generally the original drug. This may only be used as a reference listed drug once patent protection has expired. The bioequivalence or therapeutic equivalence, quality, efficacy and safety of the generic drug must be assessed in comparison with the reference listed drug. In addition, its quality, efficacy and safety must be confirmed by the results of pharmacovigilance (translation into German: Pharmakovigilanz) and GMP inspections in accordance with the specified requirements for the drugs on the market.

As professional translators and interpreters in the pharmaceutical sector, we are happy to accompany you during GMP inspections and audits, e.g. by foreign regulatory authorities such as the American FDA.

Our range of services includes not only language services but also various types of consultancy services, representation of foreign pharmaceutical companies and distribution of their products in Germany. Thanks to our long-standing cooperation with many international pharmaceutical entrepreneurs, we are able to place jobseekers in vacancies in the pharmaceutical industry. Please feel free to contact us by e-mail or telephone!