China's warning letter uptick continues in 2015


China's efforts in good manufacturing practice (GMP) certification in 2015 showed a continued shift toward warning letters even as the overall number of reviewed applications fell by more than half.

In its annual report, China FDA's Center for Food and Drug Inspection (CFDI) said the number of applications from firms for GMP certification reviewed by the end of the year fell to 221 from 482 in 2014 and from a 5-year high of 584 in 2013.

Nine of the 221 reports reviewed failed inspection, but the number of firms that received warning letters during the year reached 68, or nearly 31% of the total, a continued uptick from 30.3% the previous year and almost double the 17.8% in 2013.


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Chinese regulatory officials have pushed in the past few years for mandatory GMP certification for all drug manufacturing plants. The urgency drives from an official campaign to ensure safety to a public concerned about fake and adulterated medicines and to assure international buyers of exported products.

Along those lines, the country is said to mull membership in the drug manufacturing convention known as the Pharmaceuticals Inspection Cooperation Scheme (PIC/S).

In a separate posting, China's State Council released guidelines for a two-year pilot program in 10 jurisdictions as part of reforms of the country's pharmaceutical products marketing authorization system, including a provision related to GMP.

"For holders who are qualified to produce pharmaceutical products, they can either produce on their own or authorize qualified pharmaceutical production companies," the State Council release said.

"For those holders unqualified for production, they should choose the latter way. The authorized production company should also meet several qualifications, including being legally established within the trial zone, holding pharmaceutical production permit and certificate of Good Manufacture Practice."

- here's the CCDI report
- and the notice from the State Council


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