European Pharmacopoeia looks to international experts to help harmonization
It agreed at an official session towards the end of last year that it should open up its nomination process for exports to include candidates from outside the 37 member states of the Ph. Eur. convention and 26 official observer countries.
"Until now, only candidates from proposed from national pharmacopoeia authorities (NPAs) and by observers to the Ph. Eur. Commission were considered," said Susanne Keitel - director of the EDQM - at the IPEC Europe Excipients Forum in Nice, France, earlier this month.
"In the future, candidates … from authorities, manufacturers and academia and other interested parties from non-Ph. Eur. member states are also possible and welcome," she added.
While around 80 staff members work on the development of the Ph. Eur. within the European Directorate for the Quality of Medicines and Healthcare (EDQM), the level of work required means that they function largely as a secretariat, relying on external expertise to tackle the work required to keep the compendium up to date.
At the moment more than 700 people contribute to the elaboration of Ph. Eur. - split roughly a third apiece between health authorities, industry and academia - with input from another 60 observers from other countries including the US and Russia, amongst others.
Developments in the regulatory environment, scientific and technical developments, new risks to public health, the increased demand for generic biosimilar products and the globalisation of manufacturing and supply all make it imperative that Ph. Eur. casts its net widely when updating its texts, Keitel told the meeting.
"We know that active pharmaceutical ingredients … are predominantly manufactured outside Europe and the US, so we need to have input from the wider world" she added. Joining the network will allow international experts to "help shape Ph. Eur. texts at an early stage."
Nominations can be sent to the Ph. Eur. secretariat and as occurs at the moment the final decision on appointments will be taken by the commission.
The EDQM is in the process of finalising terms of reference and expert profiles, and will make nomination forms and other relevant documents available on its website in April.
Chinese Pharmacopeia
Shang Yue of the Chinese Pharmacopoeia (ChP) Commission also told delegates at the Excipients Forum that the organisation will welcome input from international experts as it starts work on the next version of the ChP, due in 2020.
The just-published 2015 edition represented a mammoth task with a huge increase in the number of monographs contained in the publication, but diversions from standards in place in other regions of the world have caused problems for some manufacturers importing goods into China.
ChP intends to make a list of the monographs due to be added or revised in the 2020 edition available so comments can be received from interested parties early on in the process, she said.
