PMDA participation as an observer in the EMA-FDA pilot program for Quality by Design
In March 2011, the European Medicine Agency (EMA) and the U.S. Food and Drug Administration (FDA) announced the EMA-FDA pilot program for parallel assessment of Quality by Design (QbD(note)) applications, which aims at a parallel assessment by both agencies of certain Quality/CMC sections of a selected number of applications under the confidentiality arrangements.
(note) Quality by Design; A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
This pilot program mainly focuses on consistent implementation between EU and US of ICH Q8, 9, 10 guidelines in the assessment process and to facilitate sharing of regulatory decisions on new regulatory concepts.
Pharmaceuticals and Medical Devices Agency (PMDA) participates in the EMA-FDA pilot program of QbD as an observer under the EMA, FDA and PMDA confidentiality arrangements, in order to share information and points to consider relating to QbD review.
PMDA expects its participation can facilitate increased harmonization of QbD application assessment.
PMDA participation in this pilot program is under the sponsor/applicant agreement. However, this does not mean PMDA undertakes review of the QbD application of the product in the Japanese regulatory process. At this stage, PMDA participation is limited to one application and expansion to other applications will be decided based on the evaluation of this first attendance.
In November 2011, PMDA launched a new project team consisting of reviewers and inspectors to handle the participation in this pilot program and to share common understanding of QbD between offices in PMDA.
- Questions and Answers on level of detail in the regulatory submissions (Dec.2014)
- Questions and Answers on Design Space Verification (Oct. 2013)
- EMA-FDA pilot program for parallel assessment of Quality-by-Design applications: lessons learnt and Q&A resulting from the first parallel assessment (Aug. 2013)
- About the extension of the EMA-FDA pilot program of QbD.