| The 169th session of the European Pharmacopoeia Commission took place on 23-24 March. Held virtually for the third time, attendance was higher than usual, with more than 140 people – including 60 representatives of 32 countries that have signed the Convention, 17 experts from observer States (Armenia, Azerbaijan, Belarus, Russian Federation, Georgia, Uzbekistan, India and Japan), the Taiwan Food and Drug Administration (TFDA) and the World Health Organisation (WHO) and 28 chairs of the European Pharmacopoeia’s (Ph. Eur.) 61 groups of experts and working parties taking part.During the session, the Commission adopted 68 texts, including 9 new monographs and 18 texts that had undergone technical revision (substantial modification of their scientific content). As is standard procedure at the Ph. Eur., before being submitted to the Commission these texts were published for public enquiry on the Ph. Eur.’s online commenting forum, Pharmeuropa, to give stakeholders the chance to review the proposed changes. All comments received by the EDQM (often via the various National Pharmacopoeia Authorities) are shared with the group of experts responsible for the text, which will decide on how best to deal with them. The Commission, however, always has the final say in this matter. The remaining 41 texts adopted in March had undergone “minor revision” and, again according to standard procedure, had been submitted directly for adoption without a public enquiry stage. All 68 texts will be published in supplement 7 to the 10th Edition of the Ph. Eur. The Ph. Eur. will then comprise 2847 texts, including 2464 individual monographs (including monographs on different dosage forms) and 383 more general texts (general monographs and analytical methods).This March session also saw no fewer than six new monographs and 47 revision projects added to the work programme, with the Commission also deciding to stop revision work on 4 others. Today, the Ph. Eur. work programme comprises 320 new texts to be elaborated and more than 350 submitted for technical revision. The entire work programme is reviewed annually in detail by the Commission. To this end, the chairs of the expert groups and working parties are invited to present, at one of the three annual Commission sessions, a progress report on their group’s work, including their successes and any difficulties encountered. Twenty chairs also presented their individual progress reports at this session, highlighting the successes and the difficulties encountered over the past months. While it is clear that the pandemic has had a significant impact on a number of projects, the chairs praised the experts and the Secretariat for their rapid response to the challenges of the situation and for their commitment to ensuring that the meeting schedule and work programme targets – and by extension, the publication deadlines – were maintained. |
