FDA and EMA Pilot Program for joint Review of QbD Components of new Drug Marketing Applications

International Pharmaceutical Quality (IPQ) has published interesting News about a new joint activity of FDA and EMA. They will launch a collaborative Quality by Design (QbD) Application Review Pilot. According to IPC, the pilot was announced by FDA Office of New Drug Quality Assessment (ONDQA) Director Moheb Nasr and EMA Quality Working Party (QWP) Chair Jean-Louis Robert (Luxembourg Medicines Control Laboratory) at a CMC workshop in Washington, D.C. Both Nasr and Robert have played key roles in the development of the ICH QbD paradigm as introduced in ICH Q8-10.

A basis for the QbD review pilot were the two joint inspection initiatives in which the US and EU have been participating, focusing on pre-approval inspections for finished product manufacturers. The pilot project was developed between Nasr, Robert and other key quality regulators at FDA and EMA.

In a first step, the pilot will include only chemical entities (and not biologicals), encompassing new drug applications and supplements/variations as well as scientific advice. Participation will be voluntary for companies which want to submit a filing in the US and in the EU at the same time.

The full story below would normally be available only to IPC subscribers and license holders. However you will be able to access the article.

Before launching IPQ, Bill Paulson, IPQ Editor-in-Chief, served for over two decades as the primary author of "The Gold Sheet."