FDA, EMA unveil pilot program for QbD applications parallel assessment

Reviewers from both agencies will separately assess the quality/chemistry, manufacturing and control (CMC) section of the new drug applications (NDAs) submitted to the FDA and marketing authorization applications (MAAs) submitted to the EMA.

However, there will be regular communication and consultation between European regulators and their US colleagues throughout the review process relevant to QbD aspects of the applications.

The pilot program intends to help ensure consistent implementation of International Conference on Harmonization (ICH) guidelines for manufacturing quality in the application evaluation process, increase awareness of the regulatory concepts by staff that review marketing applications and inspect manufacturing facilities as part of the approval process and, define the reviewer and inspector interaction for QbD applications.

The pilot program also plans to create a further way for EMA and FDA assessors/reviewers to share full knowledge about these applications and, develop and harmonize regulatory decisions to the greatest extent possible.

FDA Center for Drug Evaluation and Research director Janet Woodcock said as the number of applications that follow the QbD approach steadily increases, collaborative assessments will enhance understanding of QbD concepts.

"The tools used by FDA and EU reviewers will increase information sharing and reduce redundancy. To fully implement QbD, we need to further harmonize the implementation of the guidelines, work collaboratively, and provide scientific, risk-based regulatory decisions in a timely manner," Woodcock said.

This pilot program applies to NDAs and MAAs, some supplements, and CMC meeting requests that include QbD elements submitted to both agencies at about the same time.

The program will only include chemical entities and not biologically-derived products. Review of QbD applications does not change statutory deadlines.

The pilot will end on 31 March 31 2014.