SFDA hand cash to CMO whistleblowers
Informants willing to provide substantial evidence about unlawful activities in China’s drugs and medical equipment production facilities will now be handed anything from 500 yuan ($78) to 200,000 yuan ($31,000).
"The reward will be higher if the reported goods or products have not been distributed, so that we can effectively control the damage," SFDA press officer Xu Wei told the Global Times.
He added: "Informants who originally report the cases to police, but have not collected rewards from it, can apply for a reward from us.”
If plans come into force, tip offs will be gathered through anonymous phone calls, emails or letters, and rewards can be collected by a trustee.
In a statement posted on its website, the Chinese regulatory body said it is now seeking public opinion on the proposal.
Whistleblower express
The SFDA are the latest regulatory board to jump on the bandwagon after the US board began offering informants money in exchange for information.
In a landmark case against UK drugmaker GlaxoSmithKline (GSK), whistleblower Cheryl Eckhard was given a $96m payout after highlighting problems at the firm’s Cidra, Puerto Rico factory.
The Shanghai regulatory bodies’ latest move comes in the wake of its announcement it will team up with its US counterpart to bring local contract manufacturers of foreign pharmaceuticals up to scratch with Western drug standards.
Following a notice titled ‘Enhancing Regulations for Domestic Processing and Manufacturing for Foreign Pharmaceutical Companies’, the new guidelines take double-pronged approach. Pharma companies outsourcing to Shanghai will regulate procedures, and the contract manufacturing organisation (CMO) will self-assess.
As part of the action, the Shanghai FDA will also perform targeted inspections.
However the papers state that the international company is ultimately responsible for any safety or quality issues regarding the drug.
