On Friday, 4 April 2008, the US
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
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persist, and according to all parties involved, they are more than outdated.
On behalf of the European Compliance Academy (ECA)