The Future of CMC Regulatory Submissions: Streamlining Activities Using Structured Content and Data Management

Area of Science:

• Pharmaceutical regulatory science
• Data science and engineering
• Cloud computing and secure storage

Background:

• Current Chemistry, Manufacturing, and Controls (CMC) regulatory activities are largely manual and paper-based.
• Global submissions and reviews are lengthy, leading to significant variability in registered product details.
• Advancements in data engineering and secure cloud storage offer opportunities for modernization.

Purpose of the Study:

• To describe the advancements in utilizing structured content and data within pharmaceutical CMC regulatory submissions.
• To introduce Structured Content and Data Management (SCDM) as a novel solution for managing the scientific data lifecycle.
• To highlight the potential of SCDM to automate regulatory authoring and enhance regulatory review processes.

Main Methods:

• Defining Structured Content and Data Management (SCDM) as an end-to-end scientific data lifecycle process.
• Explaining the transformation of data into semantically structured blocks with metadata.
• Detailing how SCDM enables human and machine readability for automated regulatory authoring.

Main Results:

• SCDM facilitates the capture, aggregation, and transformation of scientific data for regulatory submissions.
• Automated regulatory authoring (Structured Content Authoring) becomes feasible through SCDM.
• Health authorities can access digital data beyond PDF, enriching review effectiveness, efficiency, and consistency.

Conclusions:

• SCDM represents a novel approach to content and data management in regulatory submissions.
• Modernizing CMC regulatory activities through SCDM can significantly reduce global licensing timelines.
• The adoption of SCDM can enable faster worldwide access to critical therapies.