Today, I was quoted widely in a story In-PharmaTechnologist.com published titled US API Imports for Clinical Trials Now Require Effective IND, Expert Says. The story came as a result of my recent “Outsourcing Clinical Supplies Manufacturing: Navigating US API Import Laws” webcast.
In this webcast, I shared my thoughts on what we perceive as a change regarding the import of drug supplies into the US. Specifically, that you must have an IND “in effect” before importing API/drug product. This is not a new law – it is an admittedly valid reinterpretation of 21CFR Parts 312 and 201 that now can be enforced using the Establishment Evaluation System (EES). However, import of API in advance of an effective IND has been done for years and is routinely being done today.
Based on our experience with numerous clients engaged in early phase drug development, many Ports of Entry have yet to adopt/enforce this requirement. As of January 2013, we are only aware of import refusals under this requirement for materials entering the US through Chicago.
In an upcoming ebook, I will be sharing best practices for overcoming these hurdles to ensure your clinical trials start on time. If you would like a copy, please leave your contact details in the comments section of this post. And if you have import refusal experiences you would like to share, we would particularly enjoy hearing about them as we work to assess the prevalence of this phenomenon.