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EMA/FDA: Report from the EMA-FDA Quality by Design pilot program

Following the introduction of ICH Q8, Q9 and Q10, the European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) launched a joint pilot program for the parallel assessment of applications containing Quality by Design (QbD) in 2011. To facilitate the exchange of information between the two agencies the program was laid down under US-EU Confidentiality Arrangements. Both agencies have now issued a report that addresses the outcome of the 5-year-program so far.


Here are the main points in brief:

  • During the 5-year-period the agencies received 16 requests to participate.
  • Two Marketing Authorisation Applications(MAA)/New Drug Applications(NDA), three variation/supplements and nine scientific advice applications were evaluated under this program.
  • Based on the learnings during the pilot, FDA and EMA jointly developed and published three sets of Q&A documents. The objective of these Q&A documents was to generate review guides for the assessors/reviewers and to communicate pilot outcomes to academia and industry. Additionally, these documents captured any differences in regulatory expectations due to regional requirements, e.g. inclusion of process validation information in the dossier.
  • The Japanese Authority PMDA participated as an observer.
  • The FDA-EMA pilot provided the agencies an opportunity to harmonize regulatory expectations for two precedent-setting applications reviewed under the consultative advice pathway.
  • A first continuous manufacturing based application was submitted to both agencies. As a result the areas of batch definition control of excipients, material traceability, strategy for segregation of non-conforming material, real-time release testing, GMP considerations for RTRT, validation and control strategy were harmonized.
  • In line with the scope of the QbD pilot program, joint presentations of key findings were publically presented and discussed with stakeholders at different conferences.

According to EMA and the FDA, the pilot program opened up a platform for continuous dialogue. The agencies are further exploring potential joint activities with specific focus on

  • Continuous manufacturing
  • Additional emerging technologies and
  • Expedited/accelerated assessments (e. g. Priority Medicines – PRIME, Breakthrough Designation).

This includes hosting experts from each other’s organisations to facilitate dialog and explore further opportunities.


EMA/FDA: Report

Q&A document 1

Q&A document 2

Q&A document 3

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