The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have released a report on the results of a recently completed joint pilot program for assessing applications containing Quality by Design (QbD) elements.The aim of this program was to facilitate the consistent implementation of QbD concepts introduced through International Council for Harmonization (ICH) Q8, Q9 and Q10 documents and harmonize regulatory decisions across the two regions.
To facilitate this, assessors/reviewers from the US and European Union (EU) exchanged their views on the implementation of ICH concepts and relevant regulatory requirements using actual applications that requested participation into the program. The program was initially launched for three years. Following its first phase, both agencies agreed to extend it for two more years to facilitate further harmonization of pertinent QbD-related topics. The program officially concluded in April 2016.
Based on the learnings during the pilot, the FDA and EMA jointly developed and published three sets of question and answer (Q&A) documents that also addressed comments from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), which participated as an observer. The objective of the Q&A documents was to generate review guides for the assessors/reviewers and to communicate pilot outcomes to academia and industry.
During the pilot period, the agencies received 16 requests to participate. In total, two marketing authorization applications (MAA)/new drug applications (NDA), three variation/supplements and nine scientific advice applications were evaluated under this program. One MAA/NDA was assessed under the parallel assessment pathway, with the rest following a consultative advice route.
The pilot program also provided the FDA and EMA an opportunity to harmonize regulatory expectations for the following applications that were reviewed under the consultative advice pathway:
- The first continuous manufacturing (CM)-based application submitted to both agencies. Based on the learnings from this application, the following areas related to CM were harmonized: batch definition; control of excipients; material traceability; strategy for segregation of nonconforming material; real-time release testing (RTRT) methods and prediction models; and GMP considerations for RTRT, validation strategy, models, and control strategy.
- A post-approval supplement that included a broad based post-approval change management plan/comparability protocol. Both agencies were harmonized on the expected level of detail in the protocol and considerations for implementation of a risk-based approach to evaluate the changes proposed in the protocol.
Overall, the FDA and EMA concluded that, on the basis of the applications submitted for the pilot, there is alignment between both agencies regarding the implementation of multiple ICH Q8, Q9, and Q10 concepts. Both agencies are currently exploring potential joint activities with specific focus on continuous manufacturing, additional emerging technologies, and expedited/accelerated assessments.
Source: European Medicines Agency