This is a compilation of the recent regulatory updates for China. Every week, we post an update of what's new, which you can view here.
- November 4: The China National Drug Adminstration published a new update this week on the China drug traceability system requirements. The updated guidance notes that a full end to end traceability system will be implemented for Chinese medicines. The 2022 date in the previous publication still stands, but it was reinforced that certain classes of medicines (vaccines; narcotic/psychotropic drugs; essential medicines; and those with medical insurance reimbursement) should be phased in earlier or given priority.
- September 2: Feedback from Chinese sources is that initial regulatory requirements documents were intentionally left vague to give stakeholders multiple options in how to approach compliance, including potentially different coding formats and barcode data carriers. There is industry concern around both the lack of clarity and the possibility that the requirements could change late in the game.
- August 26: New draft traceability system guidelines and coding requirements were announced with a full implementation across all medicines slated for 2022. Public feedback of the guidelines and requirements are due 9/22.
- July 15: CFDA visited GS1UK to talk about GS1 standards work in other regulatory regimes.
- June 3: The Finance and Commerce Ministries published a joint notice on improving the modern supply chain. This document is a general statement of principles and tools, and not a regulatory guideline, although GS1 standards are mentioned as potential tools. Government ministries are being solicited to publish their ideas and projects to support the modern supply chain and get federal support. The stated deadline for proposals is June 5 and projects are supposed to be completed by end of 2020 with serialization and track and trace expected to be one of the projects.
- March 4: The initial draft regulations for medical device Unique Device Identifiers were published this week.
- January 7: Following interest expressed by the CFDA on potential consideration of a GS1 standards-based traceability system, GS1 Global Healthcare is launching a stakeholder-driven China proof of concept pilot to highlight how this could work for China. The initial kickoff meeting of the GS1 Global sub-group was held 1/4.