The European Pharmacopoeia (Ph. Eur.) is a compact reference document for the quality control of medicines. Its official standards include a specific and legal basis for quality control throughout the entire product life cycle. These standards are defined by the Council of Europe Convention on the development of the European Pharmacopoeia as well as in the European Union and national pharmaceutical regulations. The European Pharmacopoeia’s quality standards become mandatory on the same day in all countries parties to the Convection.

The European Pharmacopoeia Commission (EDQM, Strasbourg) is the Ph. Eur. official decision-making body and is responsible for the development and maintenance of its content. The Commission accepts all Pharmacopoeia documents for publication and makes technical decisions by agreement. 25 representatives from Poland participates in the work of the European Pharmacopoeia Commission and its working group.

Ms. Renata Mikołajczak is a professor at the NCBJ, representative of the Director for Scientific Affairs and National and International Cooperation at the POLATOM Radioisotope Center. In the European Pharmacopoeia Commission, she will lead a working group on the development of monographs on radiopharmaceutical precursors (Precursors for Radiopharmaceutical Preparations – PRP Working Party).

Ms. Mikołajczak took up her function based on the recommendations of the Office for Registration of Medical Products, Medical Devices, and Biocidal Products, as well as after approval by the Ministry of Health and formal approval at the 166th session of the European Pharmacopoeia Commission. She is the first person from Poland to whom the Commission has entrusted such a responsible role.