This post comes from D.C. where I am attending the GPhA Fall Technical Conference. We just completed a presentation by FDA’s Glen Smith. He detailed the proposed new stability requirements for ANDA drug products. It is essentially the adoption of ICH Q1A. For readers of this blog, we know that 505(b(2) NDA’s must have 12 months real-time and 6 months accelerated stability on 3 batches at the time of filing. Until now, ANDA’s had to have just 3 months of accelerated stability data at filing to get 2 years of shelf life – confirmed later by RT data.
The new proposal is to essentially have ANDA’s have the same filing requirements as NDA’s. The only significant difference I see is that the ANDA filing would be based on 2 ‘pilot’ and one ‘smaller’ batch. OGD’s Mr. Smith would/could not answer the question as to what the ‘pilot’ size is.
The proposal is nearing the post of a draft guidance for comments after which there will be an implementation period of unannounced duration.
What does this mean for 505(b)(2) companies? It means that an ANDA will take 9 months longer before filing and cost more to develop.
Additional stability requirements, generic user fees and the increased documentation required by QbD will continue to put pressure on the smaller generic companies.