China CFDA Previews Traceability Changes With Updated GSP
On July 20, the China Food and Drug Administration (CFDA) issued an update to their Good Supply Practice (GSP) for Pharmaceutical Products specification. TraceLink has reviewed the document to report on the highlights, although more communication from China is needed before anyone will know the exact impact on China track and trace.
China has been reviewing pharmaceutical quality management and good supply practices since the beginning of the year based on extensive feedback received throughout 2015. This sweeping review has encompassed everything from quality control and product traceability to recall management for food, drugs, and medical devices, and the underlying systems used to capture, manage, and share information related to these functions. The CFDA signaled the need for a new central traceability system to replace the existing electronic monitoring system, and opened their quality and supply practices for public comment back in February.
This recent publication was the expected next step to updating their principles and amendments to existing policies that govern pharmaceutical production, distribution, and dispensation in the China supply chain. The specifications cover a wide range of issues for the China drug supply, however, so this is not specific to track and trace regulations.
Further translation, interpretation, and discussion are needed in order to fully understand the CFDA’s expectations and how the industry needs to respond. Specifically, we await crucial additional details and documentation that outline system requirements and implementation details for drug traceability. For now, we don’t know whether China serialization will change, how traceability and event tracking will occur, or what will
What We Do Know: Focus on Distribution and Dispensation
The announcement places a strong focus on changing practices throughout the supply chain, particularly in distribution and pharmacy dispensation. There are extensive details laid out for everything from cold chain management to quality control department responsibilities and distribution facilities to procurement processes.
One key part of the specification focuses on track and trace by highlighting that enterprises in drug procurement, storage, sale, transportation, and other sectors should be able to take effective quality control measures to ensure the quality of medicines and establish traceability systems in accordance with the relevant national requirements, and to enable drugs to be traced back.
This reinforces the requirements that downstream distributors and dispensers must have processes and technical systems in place to ensure drug quality and traceability. Much of this reinforcement may stem from concerns raised by industry experts that connecting to the existing drug monitoring system and complying with existing China traceability regulations was too onerous for many pharmacies and distributors in the country.
The document does not address many of the questions that pharmaceutical manufacturers have raised since the original announcements earlier in the year, such as potential changes in drug barcoding, any openness to leveraging global GS1 standards in place of existing proprietary China coding, and modifications to the publication of drug product identity to a central system. It often highlights traceability across the transportation process, however, which may become part of the future traceability system. Additionally, precursor chemicals and ingredients are mentioned more than once, indicating that there may be a growing intent to also enable traceability of the drug ingredient supply chain, although this is unclear for now.
This is the next phase in the revision of China serialization and traceability. The focus this year has been on improving the ability of downstream partners—distributors and dispensers—to participate in the drug traceability system, and on improving the overall quality of the drug supply. Changes at the manufacturer level are less clear. These proposals are informing vigorous discussion in many venues, including GS1 member groups, and will undoubtedly be a major topic at the upcoming GS1 Global Healthcare Conference in China in October. We expect more details to unfold over the next several months and we invite you to share your thoughts with the team at TraceLink.