The Chinese state Food and Drug Administration (SFDA) made the comments after the WHO added the country’s National Institutes for Food and Drug Control (NIFDC) to its list of prequalified control labs.
The regulator said the listing “demonstrates that as national drug quality control laboratory, the Institute for Chemical Drug Control of the NIFDC is compliant with WHO good practices for pharmaceutical quality control laboratories (GPCL), and is considered to be acceptable for use by United Nations agencies.”
The SFDA added that inclusion on the WHO prequalified list “also offers powerful technical support to the involvement of China-made drugs into WHO’s global purchases.”
Inspection
The WHO prequalification list – available here – comprises both national and private testing services organistations that meet the organisations laboratory practices standards.
As with other labs already on the list, the NIFDC was visited by a WHO inspection team that included representatives from at least one Pharmaceutical Inspection Cooperation Scheme (PIC/S) country, a WHO assessor and a local regulator.
API prequalification
The NIFDC’s inclusion on the list also follows just weeks after the WHO included a China-made active pharmaceutical ingredient (API) on its list of prequalified medicines, which is designed to accelerate the development of drugs for which there is great need.
The API in question is the antiviral Ganciclovir produced by Haikou City –headquartered manufacturer, Hainan Poly Pharm.