China sets February 2013 deadline for excipient regulations
pharmafile | August 14, 2012 | News story | Manufacturing and Production |Â Â China, IPEC, SFDA, TaylorÂ
China has moved swiftly ahead with new regulations governing quality rules for pharmaceutical excipients, including new requirements for pharma firms and excipient suppliers.
While the turnaround time for the new regulations has been fast, the SFDA has extended the time for compliance from October of this year to 1 February, 2013.
The new ‘Regulation on Strengthening Pharmaceutical Excipients Supervision’ was pushed rapidly through the legislature in China in the wake of a major scandal involving gelatin capsules contaminated with excessive levels of chromium.
After publication of a draft last month stakeholders were given just a few days to submit comments on the proposals. The final version – a translation of which is available here courtesy of excipient industry group IPEC Americas – was published on 1 August.
The rules lay out new responsibilities for pharma manufacturers and suppliers of excipients, placing much greater emphasis on the implementation of quality systems to introduce routine checks and measures to ensure that excipients which find their way into medicinal products, are safe and fit for purpose.
A spokesman for the SFDA told the state-run Xinhua news agency that the recent gelatin capsule case ‘exposed loopholes in supervision’ and that the new regulation “aims to fill in the blanks”.
From the perspective of drugmakers, the rules place the responsibility for the quality of excipients squarely on their shoulders and introduce requirements to audit suppliers both at the start of the business relationship and periodically throughout its duration, as well as test batches according to specifications.
A central part of the scheme relies on the use of quality agreements between drugmakers and suppliers, designed to make each party responsible for staying in line with the requirements.
Suppliers are also expected to adhere to excipient good manufacturing practices (GMPs), audit their own raw material suppliers, conduct specification testing on each batch of excipient they produce and notify their customers of any changes which may affect excipient quality.
The document separates excipients into two broad categories, namely novel excipients and excipients with high safety risk that will require approval, and other excipients which can be submitted via the existing Drug Master File (DMF) system which was set up as part of a revamp of pharma GMP in China in 2010/2011.
The regulation also introduces stricter rules for the SFDA and provincial regulatory bodies, such as more frequent inspections of manufacturers and suppliers and a commitment to enforce tougher penalties for organisations which fail to comply with the new rules.
Phil Taylor
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