Harmonisation would help excipient makers tell Chinese Pharmacopoeia Committee

The comment follows days​ after the CPC asked IPEC for industry feedback on its plans to increase the number of excipients listed in the Chinese Pharmacopoeia (CP) from 130 to nearly 400 by 2015​.

Ashland’s Priscilla Zawislak, who chairs IPEC Americas’ compendial review committee, told in-Pharmatechnologist.com that – despite only being given a week to contact members – the organisation provided feedback from a large number of firms.

“IPEC Americas received input from about 25 member companies and other companies for about half of the listed substances. IPEC Europe also provided input directly to IPEC China from their members.​

“It is very important to industry to have as many excipients as possible included in the CP. In some cases, the ones on the list to be added are very commonly used excipients in many drug products globally​.”

She explained that - at this stage - the CPC is not looking for information about specific excipients, rather it wants a list of stakeholders that can provide detailed technical feedback as the 2015 revision approaches.

“We understand that companies may be asked to provide recommended test methods, specifications and samples that could be used as reference standards. We anticipate that IPEC China will continue to be involved in the CP project and that the IPEC Federation will provide support to our colleagues in IPEC China as needed.​”

International timelines​

However, while she welcomed the CPC’s efforts and its recognition of IPEC China as a “go to” organisation for the drug excipient industry in China, Zawislak suggested that even greater international collaboration would help manufacturers.

“Ideally, industry would like to have the CP participate in harmonization of excipient monographs with the other major compendia [USP/NF, European Pharmacopoeia and the Japanese Pharmacopoeia], but we understand that that is not part of the current project.​”

Zawislak also suggested that being given more time to review such revisions would benefit both excipient makers and the CPC in future in terms of the quality of data and information available.

“China frequently does not give much time to comment on proposed regulations and projects of this type. We have conveyed in our response that we are pleased that we were asked for input and that we may be able to get more information if they can give us additional time to collect input​."