The annual meeting of the national pharmacopoeia secretariats of the member states of the European Pharmacopoeia of the European Directorate for the Quality of Medicines & HealthCare (EDQM) took place in Chișinău, Moldova, from June 5 to 7, 2024. Natalia VOLOVYK, Deputy Director for Quality of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines represented the State Pharmacopoeia of Ukraine.

The event was attended by representatives from the following countries: Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Moldova (hosts), Netherlands, Norway, Poland, Serbia, Slovak Republic, Romania, Spain, Sweden, Switzerland, and Ukraine.

The meeting was opened by the Director of EDQM, Petra Dörr. She presented the EDQM's medium-term strategy for 2024-2027, focusing on strategic goals related to the European Pharmacopoeia.

The organizers introduced the structure of the Moldovan Medicines and Medical Devices Agency (AMDM), an administrative body authorized to regulate and supervise medicinal products, pharmaceutical, and medical devices.

Natalia VOLOVYK shared information with the participants about Ukraine's ongoing process of harmonizing national legislation with EU requirements and the creation of a single state control body, as well as efforts and initiatives towards this.

Participants discussed the creation of a European Geriatric Formulary (formulary for the elderly) and agreed on its importance due to the aging population and the need for special attention to this category. It was proposed to base the recommendations on the French "Cours des Comptes" regarding the development of a similar formulary for the elderly, though this development largely falls under the competence of the Council of Europe Committee CD-P-PH.

Further, participants discussed the results of a previous survey regarding the ability of national competent authorities to cover the expenses of experts and delegates of the European Pharmacopoeia and the rational format of meetings. Representatives from 26 member countries of the European Pharmacopoeia, including Ukraine, participated in the survey. Participants emphasized the undeniable importance of face-to-face meetings while agreeing on the need to allow online participation for those who, for various reasons, cannot attend in person. To maximize the success of meetings, it was proposed that one of the three sessions of the European Pharmacopoeia Commission be held in person, with the others in a hybrid format (the June session in 2025 was chosen for the in-person meeting), monthly meetings of pharmacopoeial bodies' representatives to be held online, and annual meetings to be held in person, with the format of expert group meetings left to the discretion of the chairs.

Minor changes were proposed in the nomination process for candidates to the European Pharmacopoeia expert groups to increase flexibility and confidentiality. It was suggested to create a platform where candidates would upload their Declarations of Interest independently, while other nomination stages would remain unchanged. The new procedure is planned to be launched in the summer of 2025.

The issue of some experts/delegates' passive participation in working/expert groups was also raised, emphasizing the need to inform the Secretariat of the European Pharmacopoeia Commission for a more flexible response and the initiation of the re-election process of experts.

The problem of drug shortages and possible actions within the framework of the European Pharmacopoeia and the European drug shortage initiative were discussed. The first version of the list of critical medicines to avoid potential shortages in the EU was reviewed. The possibility of early provision of European Pharmacopoeia standards in case of health crises/urgent need (before the release of the pharmacopoeial monograph), such as during a pandemic, was considered. It was emphasized that such standards would have unofficial status, published in a separate compendium (not in the pharmacopoeia), but could potentially become the basis for the development of a pharmacopoeial monograph/standard in the future.

The following dates were proposed for the sessions of the European Pharmacopoeia Commission in 2025:

– 181st session: March 25-26, 2025 (in hybrid format)

– 182nd session: June 17-18 (in person)

– 183rd session: November 18-19 (in hybrid format)

The date and location of the next annual meeting of the national pharmacopoeia secretariats of the member states of the European Pharmacopoeia have not yet been determined. It is tentatively scheduled for May 2025.

At the invitation of the Moldovan colleagues, Natalia Volovyk visited the physical-chemical and microbiological laboratories of the Moldovan Medicines and Medical Devices Agency.


N. Volovyk with representatives of the Medical and Medical Devices Agency of Moldova

N. Volovyk with representatives of the “European Pharmacopoeia

NPA 2024 participants