181st meeting of the European Commission on Pharmacopoeia

On 25-26 March 2025, representatives of the SMDC took part in the 181st meeting of the European Commission on Pharmacopoeia via video conference.

The delegation of Ukraine to participate in the meetings of the European Commission on Pharmacopoeia was established by the Decree of the President of Ukraine No. 155/2024 dated 13.03.2024 and is headed by the Head of the SMDC Roman Isayenko.

During the event, the participants heard reports of the committee chairmen on the work during the intersessional period, considered the evaluation and adoption of new and revised monographs, general sections, and discussed the work programme and the decision to abolish animal testing in pharmacopoeial methods. The decision to abolish animal testing was made at the 180th meeting in November 2024, at which the European Commission on Pharmacopoeia agreed to remove three general sections describing the relevant tests from the Pharmacopoeia.

In addition to the above, the meeting addressed issues related to the production and quality control of mRNA vaccines and their components, in particular

– mRNA vaccines for human use

– mRNA substances for the production of mRNA vaccines

– DNA templates for the preparation of mRNA substances.

The delegates also discussed sections on plastic materials used in the manufacture of containers for pharmaceutical products.

For reference.

The European Commission on Pharmacopoeia (Ph. Eur.) is the governing body of the European Pharmacopoeia and is responsible for the development and maintenance of its content. The Ph. Eur. The Commission approves all texts for publication in Ph. Eur. and makes technical decisions by consensus.  The results of joint developments become the basis for further harmonisation of the State Pharmacopoeia of Ukraine with the European Pharmacopoeia.

The European Pharmacopoeia is a legal act used in most European countries in the manufacture of pharmaceutical products. The Pharmacopoeia includes descriptions of active and excipients, as well as methods of analysis of pharmaceutical products.

The State Pharmacopoeia of Ukraine (SPhU) is a legal act that contains general requirements for medicinal products, pharmacopoeial articles, and methods of quality control of medicinal products. The requirements of the SPhU for medicinal products are mandatory for all enterprises and institutions of Ukraine, regardless of their form of ownership, that manufacture, store, control and sell medicinal products.