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Technical Information Requirements For Monograph Review

Approved April 2014

11. Report Format and Content

  1. Title Page
  2. Introduction
    1. Brief introductory statement highlighting the principle Chemical, Physical, Manufacturing and Safety properties of the substance for review.
  3. Table of Contents
    1. Report Format and Content
    2. Table of Contents
    3. Topic of Interest
      Additional levels may be added as necessary.
      The table of contents shall be in an active format for easy navigation by reviewers.
  4. List of Abbreviations and Definition of Terms
  5. General Information
    1. Nomenclature
      1. Scientific naming
      2. Synonyms
    2. Structure
      1. Chemical class
      2. Surrogate markers
      3. Structural formula
      4. Stereochemistry
      5. Molecular formula
      6. Molecular weight
      7. Amino acid sequence
    3. General Properties
      1. Physico-chemical properties
      2. Country of origin
      3. Natural Habitat/Geographical distribution
      4. Part of plant/Stage of development
      5. Botanical fresh or dry
      6. Morphological, histological, anatomical description
      7. Current sources of the drug substance
      8. Age, health status and cultivation of donor animals
      9. Conditions of slaughter
      10. Risk assessment of infectivity viral, bacterial, prionic
      11. Method of inactivation for drug substances of viral origin
      12. Biological activity
      13. Any distribution controls imposed by regulatory authorities
      14. Critical habitat assessment (endangered)
      15. Species endangered
      16. Safe handling practices
  6. Manufacture
    1. Manufacturer(s)
    2. Manufacturing process
    3. Control of Materials
      1. Quality and control of materials
      2. Botanical certificate of authenticity
      3. Macroscopic description
      4. Microscopic description
      5. Photo of voucher specimen
      6. Appearance
      7. Chromatic or spectrographic fingerprint
      8. Publicly available quality methods
      9. Heavy metals
      10. Microbial limits
      11. Residual pesticides
      12. Adventitious toxins
      13. Foreign material or adulterants
      14. Total ash
      15. Moisture content
      16. Radioisotope contamination
      17. Quantitative assay
      18. Certification of viral security
      19. Certification of TSE security
      20. Certificate of wholesomeness
      21. Description of analytical procedures
      22. Certificate of analysis
  7. Control of the Drug Substance
    1. Specification
    2. Validation of analytical procedures
  8. Reference Standards
    1. Non-official reference standards
  9. Special Storage Conditions
    1. Special storage conditions
  10. Stability
    1. Stability of clinical batches
  11. Toxicology
    1. Acute toxicity
    2. Repeat dose toxicity
    3. Genotoxicity
    4. Carcinogenicity
    5. Reproductive toxicology
    6. Local tolerance
    7. Antigenicity
    8. Immunotoxicity
    9. Dependence
    10. Metabolites
    11. Impurities
    12. Other toxicology information
  12. Literature References
    1. Literature References used in this report
  13. List of Tables and Figures
Literature References  References