China's warning letter uptick continues in 2015

Production

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.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

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

Read more on

Suggested Articles

The second of AbbVie’s highly anticipated 2019 blockbuster candidates is here: Its crucial Humira follow-up, Rinvoq.

Bristol-Myers Squibb’s takeover of Celgene hasn’t always gone smoothly, but now a once-left-for-dead centerpiece of that deal is ready to launch.

Investors sued Novo Nordisk in Denmark, claiming it misled the public about trouble plaguing its insulin franchise—and demanding $1.75B in damages.