China: CFDA seeks feedback on regulation of online medicine trade

26-11-2017

China: CFDA seeks feedback on regulation of online medicine trade

(Source: RAPS 2017-11-26)

The China Food and Drug Administration (CFDA) is seeking feedback on draft regulations covering the online trade in medicines. CFDA has drafted the document to clarify which organizations can trade online and what infrastructure and procedures they need to do so.

Under the draft rules, drug producers, wholesale enterprises and retail chains can sell drugs online. The rules prohibit wholesale enterprises from selling directly to individual consumers and require them, and the other types of organization, to meet certain requirements to trade with permitted customers.

The requirements proposed by CFDA include the establishment of a system that makes drug sales traceable and verifiable. CFDA also expects online traders to establish drug quality and safety systems, plus mechanisms for handling consumer complaints and reporting adverse events. Firms selling to individual consumers should have an online pharmacy service and licensed pharmacist to promote rational drug use.

CFDA provides some details about what these systems will look like in practice. In the case of the adverse event reporting system, the focus is on ensuring reports are forwarded promptly.

The regulation also covers how CFDA will keep tabs on and punish illegal activities. Organizations found to have breached the rules will face hefty penalties. CFDA plans to perform on-site inspections to enforce the rules.

CFDA is accepting feedback on the draft until 30 November.

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