European Pharmacopoeia - authorities and institutions, structure

European Pharmacopoeia - authorities and institutions, structure

Poster

Yoanna Stefanova1, Emil Hristov1, Kalina Andreevska1, Sava Ognianov1, Valentina Petkova2
1Faculty of Chemistry and Pharmacy, Sofia University “St. Kliment Ohridski”, Bulgaria
2Department of Social Pharmacy, Faculty of Pharmacy, Medical University Sofia, Bulgaria

Introduction: The European Pharmacopoeia (Ph.Eur.) lists the official standards, which are the scientific basis for quality control of medicinal products throughout their life cycle. It also describes the relevant methods for the analysis of active substances, excipients and materials for primary packaging, which are used to prepare the medicinal products. Aim: To clarify the main concepts and structure related to the European pharmacopoeia, as well as the authorities and institutions that develop it. Methods: Documentary and content analysis were used. Results: The European Union is a party to the "Convention on the Development of the European Pharmacopoeia" of the Council of Europe in accordance with the Council Decision 94/358/EC. The European Directorate for the Quality of Medicines and Healthcare (EDQM) is a Directorate under the Council of Europe and is responsible for developing legally binding standards for the quality of medicines. The European Pharmacopoeia Commission is the decision-making authority on the European Pharmacopoeia and is responsible for the elaboration and maintenance of its content. The Commission adopts all the texts to be published in the Ph. Eur. and takes technical decisions by consensus. The current edition of the European Pharmacopoeia is Ph. Eur. 10. It was published in July 2019 and effective starting from January 1, 2020. Contains 2462 monographs (incl. dosage forms), 383 general texts (incl. general monographs and methods of analysis) and about 2850 descriptions of reagents.
Keywords: European Pharmacopoeia, Ph.Eur., EDQM