Golden Opportunity to Reduce Regulatory Oversight of CMC Changes

In the summer of 2008, the FDA announced a pilot program for Biotech Manufacturers to submit Expanded Change Protocols (EC Protocol). This program mimicked an earlier pilot program established in 2005 for small molecule products.

The protocols are intended to gain additional product / process characterization data and pre-approved change evaluation methods in exchange for reduced regulatory filings. In other words, a change normally filed as a CBE-30 or PAS may qualify as an Annual Report (AR) filing, when executed according to an approved EC Protocol.

The FDA initially limited the number of original applications (INDs) to five, but they have recently extended the deadline for submission and has increased the number of allowable applications to eight (see the following link, http://edocket.access.gpo.gov/2009/E9-22378.htm).

Although submitting the EC Protocol in an IND would be very advantageous for most manufacturers, it does come with a cost. It is likely to slow the progress and time to get a product to market. This being the case, only a few manufacturers can afford this luxury.

However, a single sentence in the last paragraph of the notice is rather intriguing; "FDA is also extending the deadline for submission of postapproval supplements from March 31, 2010, to March 31, 2011."

An EC Protocol submitted as postapproval supplement would not delay getting a product to market or restrict a product's marketability, while being refined through the approval process.

A savy manufacturer could submit a single EC protocol for all their facilities and products that could reduce the regulatory filing requirements for some of their most common and critical manufacturing changes.

Manufacturers don't need to request a blank check for all change supplements, but rather need to focus on getting reduced regulatory oversight on facility /equipment expansion and process improvement changes that allow them to improve their production outputs.

If interested in discussing the possibilities of reducing your regulatory oversight through a postapproval EC Protocl in more details, please contact me through my website, www.iqauditing.com.