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QbD Gaining Momentum with New Pilot Program

On March 16, 2011, the FDA and EMA announced a pilot program for parallel assessment of Quality by Design programs in new drug marketing applications. This is a very positive step forward towards regulatory harmonization and provides additional impetus for companies to adopt QbD as a standard practice for drug development. This pilot program is clear recognition that QbD guidelines are being interpreted differently by FDA and EMA member states despite the fact that these guidelines were developed and adopted through the collaborative efforts of these regulatory authorities.

Initially, the pilot program will only include chemical entities and will extend to biologics in a step-wise approach after some experience has been gained with simpler molecules. We commend the “walk before you can run” approach due to the complexities of biologics, however, we also encourage FDA and EMA to incorporate biologics into the program as soon as tenable. Since the program is scheduled to end by March 31, 2014, we hope that the regulatory authorities are ready to address biologics in time to get meaningful feedback before the pilot program ends. We’re pleased to see that one of the key components of the pilot program is the commitment to propose new topics for discussion and guidance development through ICH or regionally, as appropriate, and to make joint presentations of key findings public through conferences and/or publications.

Part of the ongoing challenge to fully implementing QbD for biologics has been the disconnect in expectations of reviewers and field investigators and the lack of clarity on the amount and type of data required to support a QbD filing. As we have pointed out before, the lack of clear guidance on exactly what type of data and how much will constitute an acceptable level to support a QbD filing has hampered full adoption of QbD. During his presentation at the recent IBC Process and Product Validation, Patrick Swan, Deputy Director, Division of Monoclonal Antibodies, Office of Biotechnology Products, CDER, FDA, noted that this question of data requirements for QbD submissions is still an open one.

Nevertheless, the pilot program’s goal of increasing awareness of the concepts of QbD is commendable. We applaud this pilot program and the continued effort to harmonize the regulatory environment, especially with respect to QbD, even though we would have liked to see more proactive language in the announcement acknowledging that more can be done to harmonize reviewers and investigators on both sides of the pond. By hopefully lowering the risks and increasing the benefits of adopting QbD, the pilot program should benefit industry and patients by helping to accelerate product approval in both markets.


Blog article by: James Blackwell and Howard Levine

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