We often assume that the medicines we take are safe. Every year, billions of doses of painkillers, diabetes treatments, antibiotics, vaccines and drugs to reduce blood pressure, cholesterol or stomach acid are prescribed and taken. Yet how many people really know how these drugs are developed and tested? Even the most common types of medication go through stringent quality control to verify their safety, largely thanks to the European Pharmacopoeia of the European Directorate for the Quality of Medicines & HealthCare (EDQM).
A pharmacopoeia is a collection of instructions on how to test the quality and safety of medicines and their ingredients. For centuries, different pharmacopoeias have been developed and used in Europe, but it wasn’t until after the Second World War that serious efforts began to harmonise the various standards used throughout the continent. Eight countries initially agreed to create a single reference framework to harmonise pharmaceutical quality standards: Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Switzerland and the United Kingdom. On 22 July 1964, 60 years ago, the Convention on the Elaboration of a European Pharmacopoeia was opened for signature. It set the scene for the European Pharmacopoeia, a collection of legally binding texts (called monographs) on the production and quality control of medicines and their ingredients, for both humans and animals in Europe.
Since then, the European Pharmacopoeia has played a pivotal role in making sure that our medicines are safe and of good quality no matter where we are in Europe. Its growth and increasing importance internationally are sure signs of the need it serves as well as of its success. The first edition in 1969 contained just over 100 monographs. Currently in its 11th edition with over 3,000 monographs, it is legally binding in 39 member states and its standards are recognised worldwide. The European Union has ratified the European Pharmacopoeia Convention and EU legislation references its standards. Another 33 observers from around the globe contribute to the work of the European Pharmacopoeia Commission, the governing body of the European Pharmacopoeia.
The European Pharmacopoeia is elaborated and published by the EDQM, a directorate of the Council of Europe which is recognised as a leading entity in protecting public health. Its broad network of dedicated stakeholders showcases the collective commitment to upholding the highest standards in pharmaceutical quality. Working together, they contribute to the European Pharmacopoeia’s continual development, making it one of the most respected and widely recognised pharmacopoeias worldwide. Now celebrating its 60th anniversary, the European Pharmacopoeia stands as a symbol of Europe’s commitment to safeguarding public health and ensuring access to good quality medicines and healthcare. Its rigorous standards have contributed to the well-being of millions of people across the continent – and far beyond.
