On Friday, 4 April 2008, the US Food & Drug Administration (FDA) surprisingly withdrew its changes to the cGMP guide published on 4 December 2007. These corrections would have been the first since the existing requirements in the 21 CFR 210/211 were originally issued in 1978.
 
The modified paragraphs were regarded as "non-controversial" as they were mainly clarifications. In both the authority's as well as in the industry's understanding they were lived and accepted practice in the past years. For that reason the changes were published as "Final Rule" without prior issuing a draft for commenting. They would have become effective on 17 April 2008. More details to the originally planned changes were also published in ECA's GMP news from 13 December 2007.
 
The industry commented the withdrawal differently. In a letter addressed to the FDA, the US Pharma Association PhARMA explicitly welcomed the changes and recommended further modifications (as announced by the FDA). However, individual companies, interest groups and consulting businesses demanded changes and clarifications, which apparently now lead to the withdrawal. It is questionable, though, whether these comments really would have resulted in an improvement. After all, now the old regulations from 1978 persist, and according to all parties involved, they are more than outdated.
 
Author:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)