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O n 27–28 September 2016, the European Directorate for the Quality of Medicines of HealthCare (EDQM) held a major International Conference in Tallinn, Estonia to celebrate the publication of the 9th edition of the European Pharmacopoeia: ‘European Pharmacopoeia: tackling future challenges of the quality of medicines together’ [1]. Among the topics covered in the programme was a workshop on Setting Pharmacopoeial Standards for biotherapeutic products. This manuscript is prepared based on the presentation entitled ‘The role of European Pharmacopoeia monographs in setting quality standards for biotherapeutic products’ at the workshop.