Checklist: Quality? Check!

Generic giant Teva pharmaceuticals takes every measure to make their medicines hit the mark.
Posted on Apr 7, 2022 | 12:10pm
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With generic medicines, safety and efficacy has already been established, says Jonathan Rousell, VP Generics Regulatory Affairs at Teva, and the brand has already been built. But obtaining international regulatory approval, he says, is still complicated, especially at a firm like Teva, with 1,160 generics in the pipeline in 2021 alone. Each country has its own regulator and approval requirements can vary.

To help ensure Teva’s generic drugs meet with regulatory approval worldwide, Teva’s R&D department—apportioned nearly $1 billion by the company in 2020—uses a “Quality by Design” method, combining a statistical, analytical, and risk-management approach to maintaining medicinal standards. Yet even after those standards have been met, a pre-approval phase, where dosage performance is compared to that of a branded equivalent, can take over a year.

Now taken globally by 200 million patients daily, Teva’s generic medicines affirm the company’s quality commitment. Learn more at tevausa.com.