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생명과학 eQMS 21개 항목

IND / IMPD Submission Readiness Checklist

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Confirms that the quality, nonclinical, and clinical content required for an Investigational New Drug application or Investigational Medicinal Product Dossier is complete before submission. Use as a pre-submission gating review.

21 CFR 312ICH M4 (CTD)EU Clinical Trials Regulation 536/2014ICH Q1/Q7

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Administrative and Regulatory

  • Are the required application forms and cover letter complete (e.g., FDA Form 1571 for IND)? *
  • Is the submission compiled in the required format (eCTD / CTD)? *
  • Are the sponsor, investigator, and monitoring commitments documented? *
  • Record the target submission date.

Quality / CMC (Module 3)

  • Is drug substance information (manufacture, characterization, control, stability) provided? *
  • Is drug product composition, manufacture, and control described? *
  • Are specifications and analytical methods provided with validation/verification status? *
  • Is stability data sufficient to support the proposed clinical use period? *
  • Is GMP manufacture of the investigational product confirmed? *

Nonclinical (Module 4)

  • Are pharmacology and pharmacokinetics data provided to support the proposed dosing? *
  • Are toxicology studies conducted under GLP and adequate to support the clinical duration? *
  • Is a safety pharmacology assessment included? *
  • Does the integrated summary support a safe starting dose? *

Clinical Protocol and IB (Module 5)

  • Is the clinical protocol complete with objectives, design, and safety monitoring? *
  • Is the Investigator's Brochure current and consistent with the submission? *
  • Are dose rationale and stopping/safety criteria justified? *
  • Are informed consent and subject protection provisions in place? *

Cross-Functional Review and Sign-off

  • Is the dossier reviewed for consistency across quality, nonclinical, and clinical sections? *
  • Are all cross-references and lifecycle/version controls verified? *
  • Is regulatory, quality, and clinical sign-off obtained before submission? *
  • Final authorization to submit. *

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