The European Pharmacopoeia is an official reference book used by professionals involved in the manufacture and control of medicines. Its objective is to define legally binding quality requirements for medicinal products and their ingredients.
The European Pharmacopoeia also has a legal status in the European Union and is recognised in EU pharmaceutical legislation as setting official EU quality standards.
The texts of the European Pharmacopoeia are prepared and updated by the expert groups and working groups which meet several times a year in Strasbourg.
The European Pharmacopoeia is widely used internationally. As globalisation and the expansion of international trade in medicines have increased the need to develop global quality standards, the Commission works closely with all Pharmacopoeia users around the world.
Members and Observers
39 Member States including France and the European Union (EU) have signed the Convention on the Development of a European Pharmacopoeia.
5 European countries, 23 non-European countries, the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare and the World Health Organisation (WHO) have observer status.