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# QbD Pilot Successes Outlined
- URL: https://www.fdaweb.com/qbd-pilot-successes-outlined/
- Published: 2017-04-20T12:00:00.000Z
- Updated: 2026-09-14T22:18:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138492

FDA and the European Medicines Agency (EMA) [say](http://www.ema.europa.eu/docs/en%5FGB/document%5Flibrary/Other/2017/04/WC500225533.pdf?ref=fdaweb.com) a five-year joint pilot program for parallel assessment of applications containing Quality by Design (QbD) elements showed “solid alignment between both agencies regarding implementation of multiple International Conference on Harmonization Q8, Q9, and Q10 concepts. The FDA/EMA QbD pilot program opened up a platform for continuous dialog which may lead to further communication on areas of mutual interest to continue the agencies’ support for innovation and global development of medicines of high quality for the benefit of patients.”

The agencies say they are exploring potential joint activities with specific focus on continuous manufacturing, additional emerging technologies, and expedited/accelerated assessments, including PRIME and Breakthrough. They also are hosting experts from each other’s organizations to facilitate dialog and explore further opportunities.

The QbD pilot evaluated two NDA/marketing authorization applications, three supplement/variations, and nine scientific advice applications. One NDA was assessed under the parallel assessment pathway, and the others followed the consultative advice route, the agencies say.