PhRMA Proposes Changes to M11 Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says it is generally supportive of the International Council for Harmonization/FDA M11 Clinical Electronic Structured Harmonized Protocol with the M11 template and technical specification. The association's comment letter says it believes the documents provide “important standards for the content, format, and structure of the M11 Clinical Electronic Structured Harmonized Protocol.” In addition, PhRMA says, the proposed technical specification will provide key technical attributes to enable the interoperable electronic exchange of protocol content between the sponsor and various regulatory authorities, thereby increasing efficiency and minimizing duplicative work and rework of content.

The letter says that while PhRMA supports the protocol, there are opportunities to revise the template and provide clarification to better facilitate its implementation and use. The Association submits specific comments and line-by-line edits.