We recently held a webinar on the topic of changes and updates to global API regulation in 2023. Teva api regulatory experts from across 5 different markets – US, EU, LATAM, Japan & China, came together to talk about what’s new in each market, and to share their insights about what to be looking out for this year and beyond.
Here are the highlights from the webinar:
Rodrigo Silva focuses on Brazil and Mexico, explaining that the main hurdle for Mexico in terms of getting registered is surpassing the need for the local inspection. In Brazil, the new CADIFA regulations came into effect, full force, as off August 2023, and he talks about the support needed locally to successfully obtain CADIFA. Similar to Mexico, he also details what has changed regarding inspection reports.
Ana Bohanek dives into US regulatory highlights, mainly the DMF relevant enhancements under GDUFA III, reauthorized in September 2022. She discusses changes to DMF solicited off-cycle amendments and the criteria for DMF review prior to ANDA submission.
Tzofit Kehat then goes over the main changes expected in the European market. She outlines the pharma legislation revision published by the European Commission that focuses on a new centralized procedure, and then details the CEP of the (near) future.
Jay Chen talks about what makes China’s emerging market unique in terms of regulation. She outlines the key trends and key products in China, and also what special requirements are needed there, such as how APIs are managed as medicines, and how only one supplier can be submitted with an ANDA. China also faces multiple challenges including different communication channels to elsewhere and how they’re going forward with digital promotion.
Lastly, Marianna Kishinevsky discusses Japan and how Teva api helps customers navigate this challenging market, in terms of new submissions and their workflows and timelines, and the preparation and lifecycles of DMFs.
