ICH M2 Business requirements - Scientific guideline
HumanScientific guidelines
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This document captures the ICH M2 business requirements to be included as input in to the development of the Next Major Version of the eCTD (eCTD NMV), with the intention to improve robustness, flexibility and long term stability of the message. The eCTD NMV will be developed jointly with the HL7 RPS project.
Keywords: Electronic common technical document (eCTD), Health Level Seven Regulated Product Submission (HL7 RPS)