US FDA to make quality document mandatory for exporters from next year

摘要

The US Food and Drug Administration (FDA) is planning to make the submission of 'Quality by Design' (QbD) related document mandatory for all the ANDA applicants from January 2013. All manufacturers exporting to the US will now have to submit an entire set of documents supporting their product, right from its inception, stage to the US regulatory authority while filing for approval. The documents submitted should support the companies claim on how effective and efficacious then-product is from the design stage itself and should show how quality has been built into the product. If the company does not submit appropriate documentation to demonstrate how they have done this evaluation and designed a high quality, consistent product there is a significant chance that their application may be rejected by FDA officials and the company may be sent a 'refuse to file' letter.