To ensure more effective communication and work, the US Pharmacopeial Convention (USP) has created sectors and regional chapters, namely: the Biological Sector, Dietary Supplements Sector, South Asia Regional Chapter, Greater China Regional Chapter, Healthcare Practices Sector, Excipients Sector, Latin American Regional Chapter, Middle East and North Africa Regional Chapter, Generics Sector, Innovation Sector, Asia-Pacific Regional Chapter, and European Regional Chapter. This allows for the efficient resolution of urgent issues in specific regions and the development of specific scientific directions. Unlike the previous approach to organizing meetings (once every 5 years involving all Convention members and observers), meetings by directions/regions take place as needed with the involvement of only interested parties, which allows for hearing everyone and responding much more effectively to challenges.
On March 21, 2023, in Basel, Switzerland, the European Regional Chapter Meeting of the United States Pharmacopeial Convention (USP) took place. The event was attended by 16 USP member organizations from the United States, Ukraine, Switzerland, the United Kingdom, Ireland, Turkey, Germany, France, Slovenia, Israel, and Belgium. The participants shared their experiences and work plans, as well as their vision of mechanisms to improve the work of USP and advance common priorities in order to ensure uninterrupted supply chains of quality medicines. Deputy Director for Science Dmytro Leontiev and Deputy Director for Quality Natalia Volovyk represented the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines at the event.
The chairperson of the meeting, USP Convention Secretary Anthony Lakavage, welcomed the participants, expressed unwavering support for Ukraine in its struggle against russian aggression, conveyed condolences to Turkey in connection with the earthquake, and presented a report on the work of USP and the progress in implementing the 15 key resolutions of the Convention for 2020-2025, which it relies on to achieve its mission. He also discussed the opportunities for Convention members.
The Chief Scientific Officer of USP, Jaap Venema, delivered a report on the latest achievements in science and standards development by USP. He noted that the USP division in India synthesized 1,000 impurities since the establishment of the Synthetics Laboratory in 2011. In the past year, USP has published the general text of <477> User-Determined Reporting Thresholds, published the first proposition as to new standards, developed the first standard on cannabis for the herbal medicines compendium (HMC), and made the general chapter of <1469> Nitrosamine Impurities official.
Participants presented their organizations and visions for cooperation. Natalia Volovyk delivered a report in which she described the mission, priority areas of work, and achievements of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, particularly in the development of national monographs of the State Pharmacopoeia of Ukraine (SPhU), the national system of reference standards, and the national proficiency testing program. She thanked USP for its steadfast position and support of Ukraine, as well as for assistance in ensuring the availability of quality medicinal products on the Ukrainian market through the right to use and adapt USP texts in SPhU, conducting training and exchange programs, and expressed hope for further cooperation.
During the discussion, participants highlighted the main directions for further joint work, including ensuring uninterrupted supply chains and safety of medicinal products, environmental sustainability, the use of green chemistry in pharmaceutical production, proper control of nitrosamines and impurities, and the development of biological preparations and biosimilars.
At the end of the meeting, the participants received letters of appreciation from Catherine Dugan, the Chair of the European Regional Division, and Alessandro Slama, the General Manager of the EMEA region.
