Pharma Track & Trace Regulations – Serialization
Last Update: November 3, 2015
Drug Counterfeiting is becoming a global issue. The United Nations have already established a Task Force to combat Drug Counterfeiting worldwide (WHO | International Medical Products Anti-Counterfeiting Taskforce — IMPACT) and more and more countries are establishing legislation to fight counterfeit drugs. Just recently (Nov. 18, 2013), the US Senate has voted for a US-wide law that ultimately will require serialization on the smallest sellable unit of pharmaceutical drugs. This blog is intended to provide some background and a brief overview on current and anticipated regulations.
Lots of different attempts are being made to combat drug counterfeiting, e.g. applying seals to the packaging to prevent unauthorized repackaging or special holographic labels. As another consequence governments throughout the world have established or will establish legislation to enable seamless tracking and tracing of each single pack of medication from the manufacturer to the point of dispensing the drug to a patient (Pharmacy, Hospital). This will be achieved through serialization of each individual packaging unit. Ultimately a consumer or pharmacist should have the ability to take a single package of any drug, scan it and get the information whether this package is genuine (Check out the securPharm — der deutsche Schutzschild gegen gefälschte Arzneimittel – YouTube: … in German…sorry!).
Why is this difficult? Serialization is a little more than slapping a number on a package even though some countries require exactly this. To comply with most regulations however the manufacturer has to keep track on the numbers and has to report them to local authorities in some cases. Secondly, the serial numbers are not really “serial”. To the contrary, serial numbers typically are random numbers from a number range. Otherwise you could easily guess the numbers once you have one package in your possession which would in turn allow counterfeiting. In some countries the numbers are even provided by government agencies (e.g. China). And to make matters even more complicate manufacturers not only have to know the serial numbers but also the aggregation of the serial numbers as the packages are bundled, then put into cases (“shippers”) and finally put on a pallet. When a pallet is shipped, you have to know which serial numbers are on this pallet as those are the numbers you have to report.
The following countries have introduced legislation to serialize pharmaceutical products (no warranty – latest update: Nov. 3, 2015):
- The Drug Quality and Security Act (DQSA – H.R. 3204) which was signed by President Obama in November 2013 has pre-empted any state laws incl. California ePedigree and the existing Florida legislation. Item level serialization will be pushed to 2017 but lot level tracking is required stating Jan. 2015. For details check DQSA – Details on the new US Regulations for Lot and Item Level Tracing!
- China has an active legislation and manufacturers have to request serial numbers for products to be produced in or to be imported into China and then report the actual serial numbers to the China FDA once they have been produced or imported.
- Turkey is also running a comprehensive Track & Trace infrastructure. Initially meant to combat insurance fraud it is now capable to completely track and trace all products entering Turkey. The track and trace system currently running in Turkey is probably the most comprehensive one.
- Argentina legislation is effective but limited to certain products. However the number of products falling under this legislation is rapidly growing. ANMAT has published a detailed specification of the central Argentina database (trazabilidat), (in Spanish) in January 2014.
- India has established legislation for all products exported from India. Since May 2015 it is clear that reporting is required and specs for the DAVA portal are available since August 24. The law requires reporting as of October 1st, 2015.
- Korea legislation for serialization became effective in 2015 and now also includes government reporting to be effective in 2016. Details have been published recently and require reporting via CSV-files.
- Brazil has a legislation (RDC54) for quite some time which was not executed. A new guidance was published by the end of 2013 which will become effective in 2016. A “Normative Instruction” was published in August 2014 that details the requirements to a large extend and the english translation of the Message Specifications was published. GS1 also worked on a specification to satify the requirements. The regulation requires serialization and government reporting both into a central database as well as along the supply chain. The current interpretation makes the manufacturer responsible for the entire suply chain which spured some debate on this requirement.Go here for more details. The legislation covered a first pilot of 3 batches to be done by Decem,ber 2015 and full traceability by December 2016. A recent RDC, published on October 22, 2015 suspended the 3-batch pilot and it is expected that the entire law will be suspended.
- The EU will follow with their own serialization requirements in 2018, as laid out in The EU Directive on Falsified Medicines, 3 years after the Delegated Act will be published which is expected to happen in the first quarter of 2016. The European Commission has in the meantime clearly decided on a stakeholder model as proposed by EFPIA. The European Huib is now opertational and is run by thze newly founded EMVO.
- Plenty of other countries are preparing legislation (Saudi Arabia (March 2016), Jordan (2017), Ukraine (2017), Russia (2017), Columbia, Mexico, …). However no details are known yet. But we are currently following up on those countries as well and I will publish any news here!
I hope this provides some background. I’ll get back on how SAP Solutions can help to comply!