Extension of the FDA Pilot Programme for Biotechnological Products

On 17 September, the FDA announced in the Federal Register of 17 September 2009 that the deadline for registering for a pilot programme was postponed. It is about the submission of information on the quality (chemistry, manufacture and controls = CMC) of biotechnological products in a so-called "expanded change protocol", which is meant to be in compliance with principles of Quality by Design and risk management.

In this context, the FDA also intends to increase the number of submissions admitted to the pilot programme.

The first call for this programme was issued on 2 July 2008. It mentioned that the new approach was to be conducted under ICH Q8(R1). This new Quality-by-Design Approach focuses on the critical quality attributes (CQAs), which are meant to ensure that the efficacy and safety as well as the properties of the product and the processes are safeguarded.

The registration period was now prolonged until 30 September 2010. It is to be assumed that there had simply been too few responses. The actual data for INDs and for post-approval changes will then have to be submitted until 31 March 2011.

The complete excerpt from the Federal Register can be found here.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)


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