China seeking comment on drug traceability changes

The Chinese government has asked for feedback on proposed changes to its medicines traceability system which may amend its barcoding requirements.

Specifically, the notice (in Chinese) from the China Food and Drug Administration (CFDA) intimates that the country may abandon the need to use serial numbers supplied by the central government, although this could not be confirmed by the time this article went to press.

According to China's regulations, as of the start of this year all pharmaceutical products sold in the domestic market - as unit, bundle, case and pallet level - need to carry a 20-digit serial number issued by the government.

The system also required aggregation - linking the individually coded packaging levels to cartons, cases and pallets used in shipping - and pharmaceutical manufacturers need to not only source the numbers from the Chinese government but also upload transactional data.

The issues with the system have been widely reported, including that the serialized code is not compliant with GS1 standards, unlike other serialization requirements around the world. Moreover, reporting data has to be uploaded manually from within China, so overseas companies cannot do so remotely.

The CFDA says it has decided to look again at the requirements after "listening to drug manufacturers, drug distributors, industry associations and expert opinion," although the amendments suggest traceability will still be a requirement.

An article in Fortune magazine suggests the CFDA's decision to suspend the Product Identification, Authentication and Tracking System (PIATS), currently operated by Alibaba Health Information Technology Ltd (Ali Health), follows complaints that it provides an unfair commercial advantage to the Alibaba unit.

The CFDA was sued last month by Hunan-based pharmacy chain Yontinhe Group, which has taken issue with the fact that Ali Health operates its own online pharmacy business that - it is alleged - benefits from the relationship.

In a statement released to the Hong Kog Stock Exchange last week, Ali Health confirmed that the CFDA "is seeking public consultation on amendment of the Good Supply Practice for Pharmaceutical Products" and "has decided to temporarily halt enforcement" of PIATS.

The company said it had not received any notice from the CFDA to cease its support of the system, adding the intention was that the running of PIATS would eventually be handed over to the government agency.

"The company continues to believe that a well-operated Drug PIATS is beneficial to society," it said.

Comments on the changes can be filed until March 23, according to a notice on the CFDA website.