The Chinese government appears to be stepping up its efforts to fight the contamination and fakery that have sullied its reputation as a drug supply source. And it's borrowing from the West to do so.
The State Food and Drug Administration is circulating a draft regulation that would improve traceability--among the country's greatest pharma weaknesses--and expand supply chain auditing for APIs, excipients and packaging, reports International Pharmaceutical Quality. The draft shows intent to align with the drug master file system in the U.S. and Europe.
The regulation, if implemented, will apply to marketed drug products registered in China. But it does not address exported APIs or excipients manufactured in China, says supply chain consortium Rx-360. Once implemented, it would be followed by more detailed guidance documents.
The Chinese regulator would require confidential filings from manufacturers, and it makes clear that primary responsibility for product quality rests on the drugmaker. It requires manufacturers to have written agreements with suppliers. And it provides for drug manufacturer audits of the makers of API intermediates and starting materials, according to Rx-360.
Drugmakers finding a discrepancy between materials received and those described in a filing must not use the material. Falsified information leads to revocation of the filing and a five-year wait before the regulator may again accept a filing from that company.