Introduction to global serialization
With hundreds of countries involved in the global pharmaceutical supply chain, and over 120 countries experiencing drug-related criminal activity in 2015 alone to compile a comprehensive document detailing the exhausting pharmaceutical serialization situation around the world would be near impossible.
All sound a bit new? Why not start at the beginning?
In this short guide, we will instead look at the guidelines in each of the world's largest pharmaceutical markets and greatest importing nations.
What are the largest pharmaceutical markets?
The global pharmaceutical market is currently approaching a total value of $1.12 tn, with approximately 65 percent of the global value resting in just 10 countries – and just under a third in the US (figures to the nearest billion):
- US ($340)
- Japan ($94)
- China ($87)
- Germany ($46)
- France ($37)
- Brazil ($31)
- Italy ($28)
- UK ($25)
- Canada ($21)
- Spain ($21)
Full figures available here.
Which countries are the largest pharmaceutical importers?
Additionally, the ten largest pharma importers in the world account for roughly 63 percent of the global pharma import market, with the US leading with approximately 17 percent of the total.
The largest import markets are as follows (figures to the nearest billion):
- US ($97)
- Germany ($54)
- Belgium ($35)
- UK ($33)
- Switzerland ($29)
- China ($25)
- Italy ($23)
- France ($23)
- Japan ($22)
- Netherlands ($14)
Full figures available here.
We will now examine the twelve largest markets and importers, including Belgium and the Netherlands.
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The US
$340 bn market and $97 bn of imports
The US is adopting a comprehensive serialization requirement package through the Drug Supply Chain Security Act, or DSCSA. Since 2015, all manufacturers’ prescription drugs must feature printed lot numbers, and every transaction must be accompanied by 3T documents detailing the transaction statement, history, and information. From 2017, generically-packaged prescription drugs were then to be serialized.
From 2018, repackagers will be required to meet these deadlines; from 2019, wholesalers; from 2020, dispensers.
Aggregation will be a requirement from 2023.
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Japan
$94 bn market and $22 bn of imports
Japan’s Ministry of Health, Labor and Welfare, or MHLW, has introduced the Implementation Guideline for Barcode Labeling of Prescription Drugs. This covered a requirement to introduce serialization by 2015, and covers the uptake of aggregation data by April, 2021.
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China
$87 bn market and $25 bn of imports
China already has obligatory serialization - however, the CFDA Decree No.28 has been officially 'on hold' since 2016, despite a deadline of 2015 having already passed. Similarly, their aggregation deadline has passed (December 2015) but has also been on hold since 2016.
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Germany
$46 bn market and $54 bn of imports
As an EU member state, the German market is rapidly approaching the February 2019 serialization deadline. The EU is also expected to introduce aggregation at some point, but it is not yet officially in the pipeline. Serialization compliance in the EU is measured against the EU Commission's Directive 2011/62/EU.
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France
$37 bn market and $23 bn of imports
As an EU member state, the French market is rapidly approaching the February 2019 serialization deadline. The EU is also expected to introduce aggregation at some point, but it is not yet officially in the pipeline. Serialization compliance in the EU is measured against the EU Commission's Directive 2011/62/EU.
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Brazil
$31 bn market
Brazil has recently passed deadlines for both serialization and aggregation - with an expansion due in 2022 to upgrade compliance from three batches to all products. The Brazilian guideline is the SNCM Sistema Nacional de Controle de Medicamentos Law No. 11.903/2009.
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Italy
$28 bn market and $23 bn of imports
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As an EU member state, the Italian market is rapidly approaching the February 2019 serialization deadline. The EU is also expected to introduce aggregation at some point, but it is not yet officially in the pipeline. Serialization compliance in the EU is measured against the EU Commission's Directive 2011/62/EU.
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UK
$25 bn market and $33 bn of imports
As an EU member state, the Italian market is rapidly approaching the February 2019 serialization deadline. The EU is also expected to introduce aggregation at some point, but it is not yet officially in the pipeline. Serialization compliance in the EU is measured against the EU Commission's Directive 2011/62/EU. The impact of Brexit on future aggregation requirements in the UK remains to be seen.
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Canada
$21 bn market
There is currently no requirement for serialization in Canada, but it is expected that the Canadian government will follow the US model for any future legislation.
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Spain
$21 bn market
As an EU member state, the Spanish market is rapidly approaching the February 2019 serialization deadline. The EU is also expected to introduce aggregation at some point, but it is not yet officially in the pipeline. Serialization compliance in the EU is measured against the EU Commission's Directive 2011/62/EU.
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Belgium
$35 bn of imports
As an EU member state, the Belgian market is rapidly approaching the February 2019 serialization deadline. The EU is also expected to introduce aggregation at some point, but it is not yet officially in the pipeline. Serialization compliance in the EU is measured against the EU Commission's Directive 2011/62/EU.
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Netherlands
$14 bn of imports
As an EU member state, the Dutch market is rapidly approaching the February 2019 serialization deadline. The EU is also expected to introduce aggregation at some point, but it is not yet officially in the pipeline. Serialization compliance in the EU is measured against the EU Commission's Directive 2011/62/EU.
If you missed the other parts of our guides, why not check parts one, two, and three?