Regulations Roundup

Global Track and Trace Update: China, Russia, Pakistan, Qatar, Brazil

February 9, 2017

As compliance requirements continue to evolve across the world, we’ll review and share the latest updates so that you’re fully prepared to conduct business in those markets. This week covers updates from the following five nations:


The State Council announced that they officially approved adoption of the 13th five-year plan for national food and drug safety. This includes plans to speed up establishing procedures that ensure all phases of medicine production and sales are traceable. Fundamentally, this finalizes the legal basis for putting forth new traceability regulations, work upon which the CFDA started in mid-2016 – expect to hear more later this month. In addition, AliHealth continues to work on their replacement central repository and reporting system, which is intended to be one option to replace the existing CN21 system.


A new Russia Pilot Decree was published on January 24th, 2017 which outlines objectives and expectations for the 2017 voluntary serialization and traceability pilot. The Pilot Decree references the previously published Drug Monitoring System Decree that lays the formal legal framework for the implementation of pharmaceutical serialization and traceability. The official system decree highlighted Russia’s two-phase approach, consisting of the voluntary pilot in 2017 with 100 percent of medicines to be covered by December 31st, 2018.


A newly regulation for the serialization of medicines that are submitted for public government tenders was published with an effective date of July 1, 2017.


A new proposed barcoding and product identification regulation has been published for drug products which are supplied to the public Hamad Medical Corporation, a major healthcare organization in Qatar. This new regulation, proposing GTIN, lot, expiry date and manufacturing date for primary, secondary and tertiary packaging of drug products, leaves open several questions for full implementation by the industry.


In late January, an ANVISA board meeting set the stage for the formation of an ANVISA Pilot Workgroup, which the governing body is developing with regulatory and industry stakeholder participants. Additional information on the scale and scope of the pilot is likely to emerge at the end of February or early March as the industry gears up for a potential start to the 1 year pilot period in later April.


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