Chinese regulators have just 11 days left to define which excipients must be licensed or require DMFs under new quality regulations due to be introduced next month.
The Chinese State Food and Drug Administration (SFDA) announced plans to regulate production and use of pharmaceutical excipients last summer (English version available here ), explaining that risk-based assessments will be used to develop a master list of compounds requiring different levels of regulatory oversight.
Under the proposed rules firms making excipients deemed to be 'high risk' will “need to get [a] drug manufacturing license and these excipients...and registration approval” while producers manufacturing lower risk compounds will need to register with the agency for filing or ‘approval management’
"For excipients need approval management, manufacturers need submit related documents according to requirement. Provincial SFDA will conduct on-site inspection and random test according to Excipients good manufacturing practice [GMP].”
But with the February 1 implementation date for the new rules fast approaching the SFDA is yet to publish details of either the excipient list or specify which registration documents manufacturers will need.
A spokesman for industry group IPEC China – which has been working with the SFDA – suggested this information is vital, telling in-Pharmatechnologist.com that: “These regulations can't really be implemented without SFDA providing further detailed guidance and clarification.”
“To the best of our knowledge, SFDA is still working on developing this information, but at this time, it's very hard to say exactly when this information will be published” he continued, adding that “we do not know if they will publish anything before February 1st but we will be monitoring this closely.”
Sharing the list with the excipients industry so near to the planned implementation date would not be unusual for the SFDA.
In February last year the agency announced plans to increase the number of excipients listed in the Chinese Pharmacopoeia from 130 to 381 by 2015 and gave IPEC China members just a week to provide feedback. The final list of monographs was published in July 2012 and can be downloaded here .