China SFDA Mandatory Serialization Update
Title: China SFDA Mandatory Serialization Update
Posted: 06/01/09
Tags: REGULATORY UPDATE, REST OF WORLD, CHINA
On April 9, 2008 China’s State Food and Drug Administration (SFDA) made it mandatory for serialization to occur on individual saleable pharmaceutical product units required for 275 therapeutic classes by December 2011. The regulation mandates all drugs sold in the Chinese marketplace not just the ones manufactured in China and can be used in conjunction with the China National Medicine Code (Similar to NDC in US).
Primary reasons for this Track and Trace initiative by China is to combat drug counterfeiting, improve patient safety, track the drug movements through the supply chain, support trace and recall, support a nationwide early warning system to alert authorities in case of abnormal drug movements as well as to make online, phone and SMS authentication available to field inspectors and end users. The timeline per phase for the initiative is:
- Phase 1 — Serialize all Track & Trace Class 1 controlled substances by October 2007
- Phase 2 — Serialize Blood Products Vaccines Class 2 controlled substances and Chinese medicine injectables by October 2008
- Phase 3 — Serialize and Track & Trace all drugs (date TBD at this time)
Many Chinese regulatory bodies have joined forces on this initiative. SFDA plans to manage a centralized nationwide database of serial numbers, issue and manage serial number for registered drugs and enforces the use of these numbers. China Drug Identification, Authentication and Tracking System (www.drugadmin.com) a division of China Product Identification, Authentication and Tracking System (PIATS) would provide an online portal for drug manufacturers and other enterprises that involve drug supply chain activities to register their products and obtain serial numbers. They would also provide online services that allow commissioned serial numbers to be activated and saved to SFDA’s database, and provide real-time authentication service for dispensers, law enforcements and consumers. All these services have a fee associated with it. The serial number for the pharmaceutical drugs would be 20 numeric digits including manufacture code, serial number, check digits (6 digit codes that has one-to-one mapping with China’s own NDC, 9 digit serial number and 4 checking/encryption digits).
To achieve serialization, drug manufacturers, re-packers and/or importers would have to register at www.drugadmin.com, pay an annual and maintenance fee to be able to receive login information and a USB key. Based on the membership, these organizations would be able to apply for a range of serial numbers online from PITAS before starting production of a batch. Once PITAS would receive the request for serial numbers by a member organization, they would issue a block of numbers (including checking/encryption digits) back to the organizations. Upon receipt, these organizations would be able to commission, print and apply serial numbers on the salable units as well as on the cases and pallets. Printing can be done online, near line or offline. Once commissioned, the serial numbers will be activated and sent to SFDA’s database via online services along with the aggregation hierarchies.
At this point and time, China has not finalized the dates for Phase 3 of the roll out. Once the SFDA receives feedback from the companies that were required to serialize in Phase 2 and the SFDA is done making all the appropriate changes to the process, they would employ a very aggressive timeline towards achieving complete compliance within China.