The guidelines – currently only available in Chinese –were issued for an extremely short four day period of public comment on June 4 and are due to come into effect on October 1.
In its introduction the State Food and Drug Administration (SFDA) says that: “Excipients are an important part of drugs that can directly affect quality and safety” and explains that the aim of the guidelines is to “further strengthen the supervision of the excipients.”
Under the proposals pharmaceutical manufacturers will be required to “conscientiously perform their audit and management of pharmaceutical excipient manufacturers and their products,” although further details of how this is to be regulated are not provided.
The draft guidelines also mention that the SFDA plans to “step up our efforts to deter illegal behaviour” by guiding pharmaceutical companies and excipient manufacturers, although again the agency does not provide more information.
The publication comes just a few months after the Chinese Pharmacopeia Committee announced plans to increase the number of excipients listed in the Chinese Pharmacopoeia – currently 130 – to at least 381 by the year 2015.
Excipient quality
Publication of the draft is also timely given that the quality of excipients in China has been in the spotlight in recent months.
In April it was discovered that a number of excipient manufacturers in China had been using gelatine derived from leather waste – rather than food-grade gelatine – in capsule–based drug products.
This prompted a large number of recalls and an ongoing investigation of production practices at excipient manufacturers across the country.
For an industry whose reputation was damaged by the heparin scandal of a few years ago – where heparin was illegally replaced with over-sulfated chondroitin sulfate (OSCS) by unscrupulous suppliers – the issues with gelatine are a further blow.
Whether the SFDA’s new guidance will be sufficient to reassure firms looking to source excipients in China remains to be seen, but clearly they suggest that regulators in the country are intent on preventing such problems in the future.