On 24th―26th May 2023, the annual meeting of the Secretariats of National Pharmacopoeial Authorities (NPA) of the European Pharmacopoeia member states took place in Helsinki, Finland. The meeting was organized by the European Directorate for the Quality of Medicines & HealthCare (EDQM). Ukraine was represented at the event by Natalia VOLOVYK, Deputy Director for Quality of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines.
During the event, four workshops were held to identify the challenges faced by national pharmacopoeias and outline ways to address them.
One of the topics discussed was the possibility of expanding the content limits for impurities in pharmaceutical preparations. Representatives from the United Kingdom, Ukraine, Switzerland, and Italy took part in the discussion. Natalia VOLOVYK emphasized the need for a mechanism for national regulatory authorities to establish content limits that differ from those specified in pharmacopoeial specifications when the information provided by the manufacturer confirms the effectiveness and safety of the medicinal product. However, there is concern that the pharmacopoeia may be excluded from the process of approving extended impurity limits, which could potentially undermine the status of the European Pharmacopoeia as the main authority in quality standardization and weaken the commitment of all stakeholders to comply with its requirements. Similar concerns were expressed by the representative of the British Pharmacopoeia. In response, representatives from Switzerland and Italy suggested that such concerns could be avoided through proper information exchange between the national regulatory authority and the national pharmacopoeia, with the latter providing information to the European Pharmacopoeia Secretariat regarding the reasoned approval of deviations from European Pharmacopoeia requirements by the regulatory authority. This highlights the need for closer collaboration between regulatory authorities and national pharmacopoeias. In most countries, this issue is addressed by establishing a national pharmacopoeial body that includes representatives from both the pharmacopoeia and the regulatory authority. Such interaction helps to receive feedback from the pharmacopoeia and develop/maintain pharmacopoeial quality standards that meet modern requirements. Therefore, it is deemed appropriate to strengthen the information exchange between the State Service of Ukraine on Medicines and Drugs Control, whose representative is the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, and the State Expert Center of the Ministry of Health of Ukraine.
Taking the opportunity, Steve HOARE, Director of Science at the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, and Natalia VOLOVYK, Deputy Director for Quality of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, exchanged signed originals of the Co-operation Agreement.
Scientific Director of the British Pharmacopoeia Commission Steve Hoare and Deputy Director of Quality at the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines Natalia Volovyk officially exchange signed copies of the Co-operation Agreement.
Natalia Volovyk with the Chair of the European Pharmacopoeia Commission Salvador Canigueral and delegate from Spain Carmen de la Morena.
Delegate from Ukraine with representatives from EDQM (from left to right: Evangelos Tasopoulus, Bruno Spieldenner, Natalia Volovyk, Cathie Vielle, Dirk Leutner).
Delegates from Ukraine, Italy, and Switzerland.
Delegates of the national pharmacopoeial bodies of member states of the European Pharmacopoeia.