The latest regulatory changes for pharma supply chains
Regulatory requirements are increasing across the globe. Here we look at three recent developments impacting pharma
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The pharmaceutical sector is already one of the most heavily regulated industries in the world. Despite this, anti-counterfeiting and security measures are growing and with ever more sophisticated tampering methods it is becoming increasingly complex to prevent fraudulent products entering the supply chain.
Here we take a look at three key changes pharma manufacturers must implement to ship their products securely.
The Drug Supply Chain Security Act
Although it was first signed into law in 2013, the US’ Drug Supply Chain Security Act (DSCSA) will finally be implemented in November 2023.
The purpose of the DCSA is to outline steps to create an electronic, traceable supply chain to prevent the entrance of counterfeit and fake medication.
To prepare for the upcoming changes, the US Food and Drug Administration (FDA) issued two draft guidances earlier this month. One addresses the use of electronic standards for tracing products through the pharmaceutical supply chain; the other deals with identifying trading partners that are authorized to track products.
The biggest change is that paper product tracing will no longer be permitted unless an exemption applies. Instead, it recommends that logistics companies and trading partners use the Electronic Product Code Information Services (EPCIS) standard to communicate information.
The False Medicines Directive (FMD)
In 2019 the European Union introduced the False Medicines Directive (FMD) to increase the security of manufacture and delivery of medication in Europe.
Under the new legislation, all new packs of prescription medicines available commercially in Europe must have a unique identifier contained in a 2D data matrix code, as well as an anti-tampering device, the format of which can vary according to the manufacturer. The data requires decoding with specialist software and is being deployed by manufacturers to prevent fraudulent drugs from being distributed.
Find out more: Simplifying the complexities of labelling and artwork
Brazil’s serialization and digital leaflets
Brazil’s government has introduced a law that requires manufacturers to include a QR code in the packaging of all medication. This must contain the same information as the written insert in the packaging, including ingredients, dosage, contraindications and expiration date. A digital insert will be accessible through a database authorized by the Brazilian National Health Surveillance Agency (ANVISA).
The purpose of this is to provide product information to the consumer by redirecting them to video or audio content, however it is not intended to replace printed information which is still mandatory.
The new legislation also updates rules around traceability. Under the new law, the party responsible for registering the product should ensure it has a system to track and trace the drugs, identifying quantities sold, distribution and recipients.
Find out more: The future of regulatory compliance and track and trace
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