IPEC Americas has issued an urgent call for drug industry feedback on China Pharmacopoeia Committee plans to expand the number of excipients listed in the 2015 edition of the Chinese Pharmacopoeia.
The China Pharmacopoeia Committee’s draft list for the 2015 revision contains 381 excipient monographs - a significant increase on the 130 listed in the 2010 version of the Chinese Pharmacopoeia.
All of the monographs in the final list will have to be met for any excipient in drugs sold in China in three years time.
IPEC China – sister organisation of IPEC Americas – has been invited to discuss the planned revision but has been asked to provide feedback by Friday 24 February – ie tomorrow.
In response IPEC Americas has asked companies interested in any of the substances in included in the draft list to provide feedback and contact details to Priscilla Zawislak (firstname.lastname@example.org ) chair of the organisation's compendial review committee.
In particular the group wants to know if interested parties are willing - at a later date - to provide comments and samples as reference standards. This information will be passed on to IPC China before being sent to the Chinese watchdog later this week.
In a statement issued today IPEC Americas said: “Please realise that the China Pharmacopoeia plans to proceed and develop monographs for all 381 substances by 2015 whether they get help from IPEC Federation members or not."