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FDAnews Drug Daily Bulletin

WHO Ends Exception to Stability Rules for Generic RH, TB Drugs

Sept. 29, 2017

The World Health Organization has dropped an exception to stability-data requirements for generic reproductive health and second-line tuberculosis drugs submitted for prequalification, the agency announced.

Because the drugs were poorly represented on the prequalification list, the agency in 2009 set stability requirements for them at three months, instead of the standard six months, to encourage submissions. The exception is no longer warranted, WHO said.

Reproductive health drugs include contraceptives, painkillers, eclampsia treatments and other products.

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