Regulatory Focus™ > News Articles > US, EU Regulators Extend QbD Pilot, Pledge Release of Further Quality Guidelines

US, EU Regulators Extend QbD Pilot, Pledge Release of Further Quality Guidelines

Posted 06 March 2014 | By

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have extended for another two years a pilot program that allows both agencies to simultaneously review quality-by-design (QbD) applications.


The pilot program was first launched in March 2011 as a means by which both agencies could communicate review findings with respect to QbD elements of applications chosen for review.

QbD refers to purposeful pharmaceutical development in which quality is designed, rather than tested, into the end product. For example, a company with proper QbD systems would have reasonable assurance that all final products were of proper quality, while one without a QbD system would presumably need to test all final products to ensure they met quality standards, throwing out those that did not.

Those QbD standards are primarily contained within the International Conference on Harmonization's (ICH) Q8, 9, 10 and 11 guidelines, which FDA, EMA and Japan's Ministry of Health, Labour and Welfare (MHLW) all recognize.

As most products now seek international market penetration, most notably in the US and EU, this now requires separate application reviews by both FDA and EMA. However, the pilot program is meant to allow for simultaneous review of certain aspects of the application-in this case, QbD elements-allowing for an expedited and more thorough review process.

Under the program, applications "are submitted to either both agencies at the same time resulting in a parallel evaluation, or either to EMA or FDA in which case the agency doing the evaluation obtains consultative advice from the other agency," EMA wrote in its Q&A document.

"This parallel assessment aids sharing of regulatory decisions and facilitates the availability of consistent quality pharmaceutical products throughout the US and EU," FDA wrote in a statement.


In August 2013, FDA and EMA announced that their initial assessment process of the pilot program had been completed.

FDA said it found the process "useful," adding that it and EMA had "reached agreement on a wide range of QbD aspects." EMA mirrored FDA's assessment, saying that it was "extremely useful to share knowledge, facilitate a consistent implementation of the ICH guidelines and to harmonise regulatory decisions to the greatest extent possible."

The regulators also released initial Q&A documents on how sponsors of applications can better implement quality elements into their applications, and in November 2013 released a new guidance document on adhering to QbD principles.

Based on the reported success of the program, both FDA and EMA have announced that they have extended the pilot for another two years.

FDA and EMA also announced that additional QbD guidance is on its way and is expected to be published in 2014.


EMA/FDA Statement

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