Emerging Markets Track and Trace Update: Russia, Saudi Arabia, Pakistan

As companies across the pharmaceutical supply chain continue preparing for U.S. DSCSA and EU FMD serialization deadlines—coming November 2017 and February 2019, respectively—regulations continue to progress in the world’s emerging markets. Today, we’ll review what compliance currently means in two countries from our last emerging markets snapshot, Russia and Saudi Arabia, as well as Pakistan.

Russia

Full implementation of serialization and compliance reporting seems to be firming up for the end of 2018,  with recent discussions strongly hinting that the original interim phases for 7HCN products, etc. will be done away with. This leaves a simple two-phase implementation approach starting with the one-year voluntary pilot phase running throughout 2017.

As mentioned in our previous Russia update, serialization requirements for details such as core data elements and field formats, as well as compliance reporting requirements for submission of traceability information and events to the central Russia repository, are all still in flux. There seems to be gradual alignment of certain serialization requirements towards common GS1 standards, but it remains to be seen how many unique Russian requirements will remain in the final regulation. The long-awaited technical implementation guideline, which should help clarify these details, has not yet been published and no clear date is on the horizon. 

Saudi Arabia

Through the recent December 6th SFDA (Saudi Food and Drug Authority) workshop, and subsequent conversations with SFDA and other officials, new details are emerging about the upcoming serialization deadlines and anticipated government compliance phase.

The existing serialization deadline of March 12, 2017  is fast approaching, with word from the Saudi regulators they will be taking this deadline very seriously. If product is not properly labeled and serialized by that date, it risks being stopped by customs or other government authorities.

Aggregation seems now to have been dropped as a formal regulatory requirement. It is still highly expected that aggregation will be a key business / trade requirement though, given the upcoming traceability and reporting requirements.

Barcoding and serialization requirements continue to track close with GS1 data standards, including the core data elements used for secondary package serialization and the lack of any formal order sequence for data elements encoded in the 2D data matrix barcode.

There are no formal dates yet for traceability and compliance reporting. However, the following information has been circulated and seems to be firming up based on recent SFDA conversations. Note, however, that the SFDA is reserving the right to change any of these criteria before a formal regulation is published:

• There will be a phased implementation by segment: manufacturer, distributor, dispenser.          
• The Turkish track and trace model will be followed.          
• The event data set is being finalized but should align pretty closely with Turkey's. 
• Normal product data elements will be included (GTIN, lot, expiry date, serial number).
• The reporting system will handle both aggregated and non-aggregated drug product.          
• Because the SFDA recognizes there will be errors and issues as companies gear up, enforcement discretion is expected. 

The potential for leveraging the central traceability system to support future consumer/patient authentication of drug products has also been mentioned as a goal.

Pakistan

While the regulatory bodies in Pakistan haven't made much progress in finalizing a new draft track and trace regulation, industry stakeholders have been pushing forward in discussions. New potential requirements being considered include a potential phased implementation of barcoding, serialization, and reporting, along with a potential industry pilot phase to test certain capabilities. We may hear more on this potential industry-led approach in the coming weeks.