Brazil Unveils First Drug-Tracking Platform

Regulators in Brazil have unveiled the country’s first drug-tracking platform, a key piece of infrastructure that will connect Anvisa and drug registration holders as they implement the country’s 2013 National Drug Control System.

The system, which must be fully adopted by December 2016, will require drugmakers to submit labels to Anvisa through XML files that display a two-dimensional barcode with a unique identifier. The system eventually will allow the regulator to track all drug movements in the country, including transport, receiving, delivery, production, importing, completion and corrections of products.

Brazilian companies are estimated to spend roughly $600 million to comply with the new requirements, said Roberto Rodrigues of Licks Attorneys in Brazil. However, he adds, the system and tracking platform under development still fail to address various traceability issues, especially regarding biosimilars.

The government purchases biologic products, including biosimilars, based on the Brazilian Common Denomination, which is the generic name of the compound. As a result, it does not differentiate between new products and follow-on products, he explained. This can cause confusion in the case of biosimilars, which are not always interchangeable with the branded version.

If a patient shows a problem with the product, it will be difficult to check whether the problem stems from the biologic or its biosimilar, said Rodrigues of the current system. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.