Final Report from the FDA-EMA pilot program for the parallel assessment of quality-by-design elements of marketing applications
FDA published the final report of its join pilot program with the European Medicines Agency (EMA) for the parallel assessment of sections of applications relevant to quality by design in April 2017:
The pilot aimed to:
support consistent implementation of quality by design concepts in international guidelines;
promote the availability of medicines of consistent quality throughout the U.S. and the European Union.
Based on the experience of conducting joint assessments, FDA and EMA have published three questions-and-answers documents to communicate the lessons learned from the program and clarify a number of details concerning regulatory submissions. These also addressed comments from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), which participated as an observer of the pilot program.
The report concludes that the both Agencies are strongly aligned on the implementation of quality by design concepts included in the ICH Q8, Q9 and Q10 guidelines.
It also foresees continued cooperation and support to innovation and global development of medicines of high quality for the benefit of patients.
The pilot was initially launched for three years in 2011 and extended until April 2016. The agencies are exploring potential joint activities with a focus on continuous manufacturing, additional emerging technologies, and expedited/accelerated assessments. FDA and EMA also host experts from each other’s agencies.
- Questions and answers on level of detail in the regulatory submissions
- Questions and Answers on Design Space Verification
- US Food and Drug Administration and European Medicines Agency release first conclusions of parallel assessment of quality-by-design applications
- Questions and Answers about FDA-EMA Parallel Assessment
- International Council for Harmonisation-Quality
- Q8, Q9, and Q10 Questions and Answers
- Q8, Q9, & Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)
- European Medicines Agency