v. 22 – Q2 2022

Market Executive Summary China’s original approach now superseded: Electronic Drug Supervision, reporting to Government DB mandatory, product identification, authentication and tracking system (PIATS) “ecode system”.

China requirements are finally aligning for the latter part to EGS. Systems are shared responsibility of stakeholders and regulatory. Vaccines are to pilot the project first half of 2020.

Revised approach to implement Drug Traceability Information System that incorporates learning from previous approach and also from established practice in other markets. The direction appears to be along setting out the principle and standards while manufacturers are mandated to establish the capability to trace drugs (item level), but at this time, no single solution is prescribed.

It is also not clear how drugs traceability will finally operate at national level. Announcements (Tencent/GS1 and pilot updates) point in the direction of a private/public partnership model leveraging the established capabilities and platform of Tencent/WeChat) and the SFDA is actively involved in traceability pilots.

The most recent requirement: Drugs of the same packaging specification can only be traced in the same traceability system.

September 2021: 2 new DRAFT standards have been issued regarding the printing and display of the drug traceability code.

Key Dates
  • “Original Approach” – eCode system: From 2012
  • Full scope: 2015 – 2016
  • Revised Approach: End of 2020: Deadline for achieving traceability for defined drug categories (key products)
  • Full Implementation – Enforcement date: January 1, 2022 (one document specifies end of 2022)
  • Q3 2021: Expected further guidance on Printing Requirements for drug traceability identification (public consultation ongoing)
  • Submission of drug annual report by 31st of August 2022
  • Serialisation / marking on all medicines from 23rd June 2023

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