China sets 2022 target for new drug traceability system

China has broken its long silence on the traceability system for medicines that will replace its earlier, controversial platform that was abandoned in 2016.

Towards the end of last month, the China National Drug Administration (CNDA) published a notice and three documents setting out its vision for the new traceability system, kicking off a consultation process that comes to an end on September 20.

There’s no English version just yet, so the usual caveats apply to this update based on auto-translated texts. That said, it seems the proposed deadline for the new system is 2020, based on a unique drug traceability code (DTC) affixed to the medicine pack, and will be implemented in a stepwise fashion.

Manufacturing authorization holders (MAHs) are responsible for building the traceability system, either their own or from a third-party supplier, with guidance from the national drugs authority which will set up an overarching “collaborative service platform” to handle data exchange.

Provincial governments will also have to get involved in the supervision and enforcement of the system and develop local traceability platforms, according to the CNDA. And each actor in the supply chain, from pharma manufacturer through wholesalers and distributors to the final seller or dispenser have to be able to check the upstream pedigree of the medicine pack.

The DTC can be composed of numbers, letters and symbols, and the code length should be no less than 10 characters, it says. It should link to the name of the license holder, the name of the manufacturer, the generic name, the drug approval number, the drug standard code, the dosage form, the formulation and packaging specification, date of manufacture, batch number, and expiration date

The documents lay out several key tasks, namely: assigning unified traceability code and data exchange standards (as yet unspecified); developing the IT platforms to executive the traceability system; promoting the interoperability of the system; expanding the value of the traceability information via a ‘big data’ early-warning system for emerging issues such as quality failures; and ensure that the data generated by the system is secure.

The scope of the proposals seems broad at present, with only traditional Chinese medicines, raw materials and certain compounded drugs exempted from the outset. Unique code data must be retained for at least five years, says the CNDA.

The intention is to allow medicines to be traced throughout the supply chain back to the manufacturer or source, prevent counterfeit and substandard drugs entering the legitimate supply chain, and make it easier to handle recalls of there is a quality or safety issue. It will also raise public awareness of drug traceability and the reasons behind it, says the guidance.

China’s last attempt at a traceability system for medicines was the PIATS (Product Identification, Authentication and Tracking System), developed by Alibaba’s AliHealth unit, which fell out of favour on the grounds that it was anti-competitive.

AliHealth has since updated the system and has been offering it to pharma companies as a voluntary scheme.

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