Clinically relevant specifications setting benchmarking survey

The objective of this survey was to gather feedback on two key areas:

  • Company position as part of the initial submission Biologics License Applications (BLA) / Marketing Authorization Application (MAA) supplement/variation, etc.)
  • Outcome of health authority review and approval of the submission (BLA/MAA, supplement/variation)

It has initially focussed on clinically relevant specifications and was designed and completed by technical and regulatory experts.

The Accelerate CMC Development to Marketing Application and CMC Regulatory team plans to use the results of the survey and subsequent discussions to support a  paper on Developing patient-centric specifications for accelerated biopharmaceutical programs. The aim of the paper is to create discussion in industry and regulatory agencies on approaches to develop quality biopharmaceutical specifications at speed, propose strategies to challenge current industry practice and engage regulatory authorities.

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