PMDA is ready for the participation of the extended EMA-FDA pilot program for Quality by Design as an observer.
In March 2014, EMA and FDA announced the two-year extension of the joint pilot program for the parallel evaluation of QbD applications. (EMA web site / FDA web site)
PMDA has been participating in the pilot program since December 2011, and involved in one parallel assessment application and one biotech product that followed the consultative advice pathway. In addition, we gave some comments on two sets of Q&As which have already published.
Now, PMDA is willing to participate in the pilot program as an observer again, expecting that our activity would facilitate QbD applications and harmonization in assessment among three regions.
PMDA believes that it brings a good opportunity for sponsors to get each regulator’s perspective and comments on QbD , and that it will become a driving force for the efficient global development.
PMDA welcomes for sponsors participating in the pilot program. If you would expect to obtain feedback from PMDA, we recommend you to ask EMA or FDA for PMDA’s participation as an observer.