The annual meeting of Secretaries of National Pharmacopoeia Authorities (NPAs) is ongoing (19 to 21 May). The meeting, originally scheduled to take place in Helsinki, Finland, is again being held virtually, with representatives from 27 of the 39 member states in attendance. Organised and chaired by the EDQM, the aim of these meetings is to facilitate and coordinate activities of common interest, provide a forum for information sharing and promote exchange and reflection on working methods within the member states. The topics addressed are therefore varied. This year’s agenda includes an exchange of experiences with Extranet, one of the IT systems developed by the EDQM. Extranet allows the secure exchange of meeting agendas and reports, draft texts and other official documents, most of which are confidential, with the NPAs, the experts and the European Pharmacopoeia (Ph. Eur.) Commission. It is also used to collect comments, mainly from experts and delegations, on draft texts. These two-way discussions give NPAs the opportunity to share their practical experience and suggest possible improvements to the tool, but also allow the EDQM to inform NPAs of possible future changes. In terms of working methods, the meeting will give NPAs advance notification of a change in the way modifications made to Ph. Eur. texts are flagged for users. The change in approach is the result of the regular review of the Ph. Eur. text elaboration and revision processes, carried out according to the principle of continuous improvement. The aim is to make the publication process even more secure while at the same time providing users with greater transparency on changes to texts. This discussion topic will be an opportunity for NPAs to ask questions, make proposals and ultimately be able to play their role as NPA representative within their organisation with confidence. Another topic discussed this year is the possibility of adding a new chapter "Design of Experiments" to the Ph. Eur. work programme. The Ph. Eur. is already active in the field of chemometrics, a discipline that relies on mathematical, statistical and other formal numerical methods together with computer science. Several chapters in this area have already been published in the Ph. Eur. The purpose of this agenda item is to discuss, in a collegial manner, the merits of developing another chapter while striking a balance between the resources needed for its elaboration and its expected benefits for users of the Ph. Eur. As always, the final decision on whether or not to add a topic to the Ph. Eur. work programme rests with the Ph. Eur. Commission, which is the sole decision-making body for the Ph. Eur. However, thanks to the elements collected during the discussion at this meeting, the Commission will be able to take a well-informed decision. In the same spirit, other subjects of strategic importance were added to the agenda, such as the principles for the elaboration of monographs on medicinal products containing chemically defined active substances or the suppression from the Ph. Eur. of the monograph on Gonadotrophin, equine serum, for veterinary use (0719). The results of the discussions will undoubtedly help the Commission to take the best possible decision at a forthcoming session or to determine what additional steps need to be taken to prepare such a decision. |