The European Pharmacopoeia (Ph. Eur.): Your Passport to Medicine Quality in Europe

The European Pharmacopoeia (Ph. Eur.), published by the European Directorate for the Quality of Medicines & HealthCare (EDQM), is a cornerstone of pharmaceutical regulation in Europe. This legally binding reference work sets standards that impact not only the European Union but ripple throughout the global pharmaceutical industry.

What is the European Pharmacopoeia?

• A Compendium of Quality Standards: The Ph. Eur. contains detailed monographs outlining the required specifications for active pharmaceutical ingredients, excipients, and finished drug products. These include tests and criteria for identity, purity, strength, and performance.
• Methods & Guidelines: It includes general chapters providing scientifically validated methods for analysis and testing, ensuring consistency and accuracy.
• Reference Standards: The EDQM provides physical reference standards used to calibrate instruments and validate methods.

Why is the European Pharmacopoeia Important?

• Protecting Public Health: The Ph. Eur. is a fundamental tool in guaranteeing the safety, efficacy, and quality of medicines for the people of Europe
• Regulatory Foundation: Compliance with Ph. Eur. standards is a mandatory requirement for obtaining marketing authorization (approval to sell) for a medicine within its member states.
• Global Benchmark: Over 100 countries outside of Europe recognize or incorporate the Ph. Eur., making it a truly international quality standard.

How Does the Ph. Eur. Work?

• Expert Collaboration: Scientific experts from member states, observer countries, and international organizations develop and revise the Ph. Eur.'s content.
• Regular Updates: The Ph. Eur. is published three times a year with supplements, ensuring it remains aligned with evolving scientific knowledge and industry needs.