You are here

Data requirements matrix for RCMs

Print version

ARGCM Part D: Registered complementary medicines

29 October 2017

The registered complementary medicines data requirements matrix (the 'matrix') provides a summary of the documents required for:

  • new registered complementary medicines
  • changes to existing registered complementary medicines.

Common technical document (CTD)

The Common Technical Document (CTD) sets out the format for an application when applying to register a medicine on the ARTG. The minimum requirements for the format and structure of registered complementary medicines dossier is described within the Minimum requirements section of this guidance.

CTD specifies the:

  • organisation of the information across 5 modules:
    • Module 1: Administrative information and prescribing information for Australia
    • Module 2: Summaries of quality, safety and clinical data
    • Module 3: Quality
    • Module 4: Non-clinical data (safety)
    • Module 5: Clinical data (efficacy)
  • order in which information must appear so they:
    • are grouped logically
    • can be easily located.

Under the CTD format:

The General dossier requirements apply to complementary medicines registration applications.

Minimum requirements (registered complementary medicines)

The actual content of the dossier will vary according to the application category.

If you are unable to submit a full CTD dossier, the minimum structural requirement for registered complementary medicine dossiers consists of a single pdf document for each module.

To maintain this structure, organise the document content using the CTD headings (combination of module number and module name). Further information on CTD modules, including CTD heading can be found at: Common Technical Document (CTD).

For electronic dossiers, headings must be bookmarked and/or hyperlinked to the module table of contents and the entire document must be text searchable (generated from electronic source documents and not from scanned material).

Where information is required but not available

Where data or literature-based evidence is required, but not available for a particular CTD heading, provide a scientific justification under that heading to explain why it hasn't been included.

We will assess the content and merit of a justification (i.e. whether the alternative approach is in fact valid) during the evaluation phase.

For some complementary medicine registration applications, certain parts of the CTD are not relevant. The data requirements matrix indicates documents that are not relevant; no justification is required in these instances.

How to use the matrix

After you have determined the appropriate application category, use the matrix to obtain an 'at a glance' indication of which documents you need to provide.

The information included in CTD Module 1 guidance will also provide assistance in determining whether the documents will be required.

The references in the matrix are:

  • R (red): the document(s) and/or appropriate scientific justification for not providing document(s) are required for a valid application.
  • D (green): the document(s) is dependent on the kind of application in a particular category for the particular dossier. For example 'D' is listed for Product information in Module 1.
  • O (blue): the document(s) is optional. There is no requirement for the document to be submitted with the application. However, the document(s) can be provided if the applicant considers the information is relevant to the application.
  • Where there is no reference (blank): the document(s) are not relevant and should not be submitted.

How to access a pdf document

For full folder names, refer to ICH guidance: Appendix 3: General Consideration for the CTD Modules (pdf,726kb).

Open all | Close all
If you want to print all details, you need to Open all before you print.

New registration: data requirements matrix

Please review in combination with the CTD Module 1: registered complementary medicines.

Module Name RCM 1 RCM 2 RCM 3 RCM 4 RCM 5 File or folder name
1 Correspondence R R R R R 100-correspondence
1.0.1 Cover letter R R R R R 1001-cover
1.1 Table of Contents R R R R R 101-toc
1.2 Administrative information D D D D D 102-admin-info
1.2.3 Patent certification D D D D D 1023-pat-cert
1.2.5 Form for approval to use a restricted representation O O O O O 1025-res-rep
1.2.6 Form for proposing a name for a new substance O O O O O 1026-new-sub
1.3 Medicine information and labelling D D D D D 103-med-info
1.3.1 Product Information and package insert D D D D D 1031-pi
1.3.1.1 Product information - clean D D D D D 10311-pi-clean
1.3.1.2 Product information - annotated D D D D D 10312-pi-annotated
1.3.1.3 Package insert D D D D D 10313-pack-ins
1.3.2 Consumer Medicine Information (CMI) D D D D D 1032-cmi
1.3.2.1 CMI - clean D D D D D 10321-cmi-clean
1.3.2.2 CMI - annotated D D D D D 10322-cmi-annotated
1.3.3 Label mock-ups and specimens R R R R R 1033-mock-ups
1.4 Information about the experts     R R R 104-experts
1.4.1 Quality     R D R 1041-quality
1.4.2 Non-clinical       D R 1042-nonclinical
1.4.3 Clinical       D R 1043-clinical
1.5 Specific requirements for applications D D D D D 105-specific
1.5.1 Literature-based submission documents       D D 1051-lit-based
1.5.5 Letters of authorisation D         1055-co-marketed
1.5.7 CM medicine assurances R R D D D 1057- assurance
1.5.8 Umbrella branding assessment       D D 1058-umbrella-br-assess
1.7 Compliance with meetings and pre-submission processes D D D D D 107-compliance
1.7.1 Details of compliance with pre-submission meeting outcomes D D D D D 1071-pre-sub-outcomes
1.7.2 Details of any additional data to be submitted D D D D D 1072-additional-data
1.8 Information relating to pharmacovigilance     D D D 108-pharmacovigilance
1.9 Summary of biopharmaceutic studies       D D 109-biopharm
1.9.1 Summary of bioavailability or bioequivalence study     D D D 1091-ba-be
1.11 Foreign regulatory information D D D D D 111-foreign
1.11.1 Foreign regulatory status D D D D D 1111-status
1.11.2 Foreign product information O O D D D 1112-pi
1.11.3 Data similarities and differences O O D D D 1113-similarities
1.11.4 Foreign evaluation reports O O D D D 1114-eval-reports
Module Name RCM 1 RCM 2 RCM 3 RCM 4 RCM 5 File or folder name
2 CTD Summaries           m2
2.2 Introduction     O O O 22-intro
2.3 Quality overall summary       D R 23-qos
2.4 Nonclinical overview       D R 24-nonclin-over
2.5 Clinical overview       D R 25-clin-over
2.6 Nonclinical written and tabulated summaries       O O 26-nonclin-sum
2.7 Clinical summary       O O 27-clin-sum
Module Name RCM 1 RCM 2 RCM 3 RCM 4 RCM 5 File or folder name
3 Quality     R D R m3
3.2.S Drug substance           32s-drug-sub
3.2.S.1 General Information           32s1-gen-info
3.2.S.1.1 Nomenclature     R D R nomenclature
3.2.S.1.2 Structure     R D R structure
3.2.S.1.3 General Properties     R D R general-properties
3.2.S.2 Manufacture           32s2-manuf
3.2.S.2.1 Name address and responsibility of each manufacturer     O D O manufacturer
3.2.S.2.2 Description of manufacturing process and process controls     O D O manuf-process-and-controls
3.2.S.2.3 Control of materials     O D O control-of-materials
3.2.S.3 Characterisation     R D R 32s3-charac
3.2.S.3.1 Elucidation of structure and other characteristics     R D R elucidation-of-structure
3.2.S.3.2 Impurities     R D R impurities
3.2.S.4 Control of Drug Substance     R D R 32s4-contr-drug-sub
3.2.S.4.1 Specification     R D R 32s41-spec
3.2.S.4.2 Analytical Procedures     R D R 32s42-analyt-proc
3.2.S.4.3 Validation of analytical procedures     R D R 32s43-val-analyt-proc
3.2.S.4.4 Batch analysis     R D R 32s44-batch-analys
3.2.S.4.5 Justification of Specification     R D R 32s45-justif-spec
3.2.S.5 Reference standards or materials     R D R 32s5-ref-stand
3.2.S.6 Container closure     R D R 32s6-cont-closure-sys
3.2.S.7 Stability     R D R 32s7-stab
3.2.S.7.1 Stability summary and conclusion     R D R stability-summary
3.2.S.7.3 Stability data     R D R stability-data
3.2.P Drug product     R D R 32p-drug-prod
3.2.P.1 Description and composition of the drug product     R D R 2p1-desc-comp
3.2.P.2 Pharmaceutical development     R D R 32p2-pharm-dev
3.2.P.2.1 Components of the drug product (heading)     R D R  
3.2.P.2.1.1 Drug Substance
compatibility
    R D R  
3.2.P.2.1.2 Choice of the excipients listed in 3.2.P.1     R D R  
3.2.P.2.2 Drug Product (heading)     R D R  
3.2.P.2.2.1 Formulation development     R D R  
3.2.P.2.2.2 Overages     R D R  
3.2.P.2.2.3 Physicochemical and biological properties     R D R  
3.2.P.2.3 Manufacturing process development     R D R  
3.2.P.2.4 Container Closure System     R D R  
3.2.P.2.5 Microbiological attributes     R D R  
3.2.P.2.6 Compatibility     R D R  
3.2.P.3 Manufacture     R D R 2p3-manuf
3.2.P.3.1 Manufacturers     R D R manufacturers
3.2.P.3.2 Batch formula     R D R batch-formula
3.2.P.3.3 Description of manufacturing process and process controls     R D R manuf-process-and-controls
3.2.P.3.4 Control of critical steps and intermediates     R D R control-critical-steps
3.2.P.3.5 Process validation and/or evaluation     R D R process-validation
3.2.P.4 Control of excipients D   R D R 32p4-contr-excip
3.2.P.4.1 Specifications D   R D R specifications
3.2.P.4.2 Analytical procedures D   R D R analytical-procedures
3.2.P.4.3 Validation of analytical procedures D   R D R validation-analyt-procedures
3.2.P.4.4 Justification of specifications D   R D R justification-of-specifications
3.2.P.4.5 Excipients of human or animal origin D   R D R excipients-human-animal
3.2.P.4.6 Novel excipients D   R D R novel-excipients
3.2.P.5 Control of drug product     R D R 32p5-contr-drug-prod
3.2.P.5.1 Specifications     R D R 32p51-spec
3.2.P.5.2 Analytical procedures     R D R 32p52-analyt-proc
3.2.P.5.3 Validation of analytical procedures     R D R 32p53-val-analyt-proc
3.2.P.5.4 Batch analysis     R D R 32p54-batch-analys
3.2.P.5.5 Characterisation of impurities and requirements for non-pharmacopoeial products     R D R 32p55-charac-imp
3.2.P.5.6 Justification of specifications     R D R 32p56-justif-spec
3.2.P.6 Reference standards or materials     R D R 32p6-ref-stand
3.2.P.7 Container closure system     R D R 32p7-cont-closure-sys
3.2.P.8 Stability     R D R 32p8-stab
3.2.P.8.1 Stability summary and conclusion     R D R stability-summary
3.2.P.8.3 Stability data     R D R stability-data
Module Name RCM 1 RCM 2 RCM 3 RCM 4 RCM 5 File or folder name
4 Nonclinical (safety)           m4
4.1 Table of contents O O O O O 41-toc
4.2 Nonclinical study reports       D R 42-stud-rep
4.2.1 Pharmacology       D R 421-pharmacol
4.2.1.1 Primary pharmacodynamics       D R 4211-prim-pd
4.2.1.2 Secondary pharmacodynamics       D R 4212-sec-pd
4.2.1.3 Safety pharmacology       D R 4213-safety-pharmacol
4.2.1.4 Pharmacodynamic drug interactions       D R 4214-pd-drug-interact
4.2.2 Pharmacokinetics       D R 422-pk
4.2.2.1 Analytical methods and validation reports       D R 4221-analyt-met-val
4.2.2.2 Absorption       D R 4222-absorp
4.2.2.3 Distribution       D R 4223-distrib
4.2.2.4 Metabolism       D R 4224-metab
4.2.2.5 Excretion       D R 4225-excr
4.2.2.6 Pharmacokinetic drug interactions       D R 4226-pk-drug-interact
4.2.2.7 Other pharmacokinetic studies       D R 4227-other-pk-stud
4.2.3 Toxicology       D R 423-tox
4.2.3.1 Acute toxicity       D R 4231-acute-tox
4.2.3.2 Repeat dose toxicity       D R 4232-repeat-dose-tox
4.2.3.3 Genotoxicity       D R 4233-genotox
4.2.3.3.1 In vitro       D R 42331-in-vitro
4.2.3.3.2 In vivo       D R 42332-in-vivo
4.2.3.4 Carcinogenicity including supportive toxicokinetics evaluations       D R 4.2.3.4
4.2.3.4.1 Long-term studies       D R 42341-lt-stud
4.2.3.4.2 Short or medium term studies       D R 42342-smt-stud
4.2.3.5 Reproductive and developmental toxicity       D R 4235-repro-dev-tox
4.2.3.5.1 Fertility and early embryonic development       D R 42351-fert-embryo-dev
4.2.3.5.2 Embryo-foetal development       D R embryo-fetal-dev
4.2.3.5.3 Prenatal and postnatal development       D R 42353-pre-postnatal-dev
4.2.3.5.4 Studies in the offspring (juvenile animals are dosed and /or further evaluated)       D R 42354-juv
4.2.3.6 Local tolerance       D R 4236-loc-tol
4.2.3.7 Other toxicity studies       D R 4237-other-tox-stud
4.2.3.7.1 Antigenicity       D R 42371-antigen
4.2.3.7.2 Immunotoxicity       D R 42372-immunotox
4.2.3.7.3 Mechanistic studies       D R 42373-mechan-stud
4.2.3.7.4 Dependence       D R 42374-dep
4.2.3.7.5 Metabolites       D R 42375-metab
4.2.3.7.6 Impurities       D R 42376-imp
4.3 Literature references       D R 43-lit-ref
Module Name RCM 1 RCM 2 RCM 3 RCM 4 RCM 5 File or folder name
5 Clinical           m5
5.1 Table of contents       O O 51-toc
5.2 Tabular listing of all clinical studies       D R 52-tab-list
5.3 Clinical study reports       D R 53-clin-stud-rep
5.3.1 Reports of biopharmaceutic studies       D R 531-rep-biopharm-stud
5.3.2 Reports of studies pertinent to pharmacokinetic using human biomaterials       D R 532-rep-stud-pk-human-biomat
5.3.3 Reports of human pharmacokinetic studies       D R 533-rep-human-pk-stud
5.3.4 Reports of human pharmacodynamic studies       D R 534-rep-human-pd-stud
5.3.5 Reports of efficacy and safety studies (header)       D R 535-rep-effic-safety-stud
5.3.5.1 Study reports of controlled clinical studies pertinent to the claimed indication       D R 5351-stud-rep-contr
5.3.5.2 Study reports of uncontrolled clinical trials       D R 5352-stud-rep-uncontr
5.3.5.3 Reports of analysis of data from more than one study       D R 5353-rep-analys-data-more-one-stud
5.3.5.4 Other clinical study reports       D R 5354-other-stud-rep
5.3.6 Reports of Post-Marketing Experience       D D 536-postmark-exp
5.4 Literature references       D R 54-lit-ref

Change to existing ARTG entry: data requirements matrix

Module Name C1 C2 C3 C4 File or folder name
1 Correspondence R R R R 10-correspondence
1.0.1 Cover letter R R R R 101-cover
1.1 Table of Contents R R R R 11-toc
1.2 Administrative information D D D D 102-admin-info
1.2.3 Patent certification D D D D 123-pat-cert
1.2.5 Form for approval to use a restricted representation O O O O 125-res-rep
1.3 Product information and package insert D D D D 103-med-info
1.3.1 Product Information and package insert D D D D 131-pi
1.3.1.1 Product information - clean D D D D 1311-pi-clean
1.3.1.2 Product information - annotated D D D D 1312-pi-annotated
1.3.1.3 Package insert D D D D 1313-pack-ins
1.3.2 Consumer Medicine Information (CMI) D D D D 132-cmi
1.3.2.1 CMI - clean D D D D 1321-cmi-clean
1.3.2.2 CMI - annotated D D D D 1322-cmi-annotated
1.3.3 Label mock-ups and specimens D D D D 133-mock-ups
1.4 Information about the experts     D D 14-experts
1.4.1 Quality     D D 141-quality
1.4.2 Non-clinical     D D 142-nonclinical
1.4.3 Clinical     D D 143-clinical
1.5 Specific requirements for applications D D D D 15-specific
1.5.1 Literature-based submission documents     D D 151-lit-based
1.5.5 letters of authorisation         155-co-marketed
1.5.7 CM medicine assurances         157- assurance
1.5.8 Umbrella branding assessment     D D 158-umbrella-br-assess
1.7 Pre-submission outcomes D D D D 1-7-compliance
1.7.1 Details of compliance with pre-submission meeting outcomes         1071-pre-sub-outcomes
1.7.2 Details of any additional data to be submitted         1072-additional-data
1.8 Information relating to pharmacovigilance     D D 18-pharmacovigilance
1.9 Summary of biopharmaceutic studies   D D D 19-biopharm
1.9.1 Summary of bioavailability or bioequivalence study     D D 191-ba-be
1.11 Foreign regulatory information D D D D 111-foreign
1.11.1 Foreign regulatory status D D D D 1111-status
1.11.2 Foreign product information D D D D 1112-pi
1.11.3 Data similarities and differences D D D D 1113-similarities
1.11.4 Foreign evaluation reports D D D D 1114-eval-reports
Module Name C1 C2 C3 C4 File or folder name
2 CTD Summaries         m2
2.2 Introduction     O O 22-intro
2.3 Quality overall summary         23-qos
2.4 Nonclinical overview     O O 24-nonclin-over
2.5 Clinical overview     D D 25-clin-over
2.6 Nonclinical written and tabulated summaries     D D 26-nonclin-sum
2.7 Clinical summary     D D 27-clin-sum
Module Name C1 C2 C3 C4 File or folder name
3 Quality   D D   m3
3.2.S Drug substance         32s-drug-sub
3.2.S.1 General Information         32s1-gen-info
3.2.S.1.1 Nomenclature         nomenclature
3.2.S.1.2 Structure         structure
3.2.S.1.3 General Properties   D D   general-properties
3.2.S.2 Manufacture         32s2-manuf
3.2.S.2.1 Name address and responsibility of each manufacturer   D D   manufacturer
3.2.S.2.2 Description of manufacturing process and process controls   D D   manuf-process-and-controls
3.2.S.2.3 Control of materials   D D   control-of-materials
3.2.S.3 Characterisation   D D   32s3-charac
3.2.S.3.1 Elucidation of structure and other characteristics   D D   elucidation-of-structure
3.2.S.3.2 Impurities   D D   impurities
3.2.S.4 Control of Drug Substance O D D   32s4-contr-drug-sub
3.2.S.4.1 Specification O D D   32s41-spec
3.2.S.4.2 Analytical Procedures O D D   32s42-analyt-proc
3.2.S.4.3 Validation of analytical procedures O D D   32s43-val-analyt-proc
3.2.S.4.4 Batch analysis O D D   32s44-batch-analys
3.2.S.4.5 Justification of Specification O D D   32s45-justif-spec
3.2.S.5 Reference standards or materials   D D   32s5-ref-stand
3.2.S.6 Container closure   O O   32s6-cont-closure-sys
3.2.S.7 Stability   D D   32s7-stab
  Stability summary and conclusion   D D   stability-summary
  Stability data   D D   stability-data
3.2.P Drug product         32p-drug-prod
3.2.P.1 Description and composition of the drug product   D D   2p1-desc-comp
3.2.P.2 Pharmaceutical development   D D   32p2-pharm-dev
3.2.P.2.1 Components of the drug product (heading)   D D    
3.2.P.2.1.1 Drug Substance
compatibility
  O O    
3.2.P.2.1.2 Choice of the excipients listed in 3.2.P.1   O O    
3.2.P.2.2 Components of the drug product (heading)   D D    
3.2.P.2.2.1 Formulation development   D D    
3.2.P.2.2.2 Overages D D D    
3.2.P.2.2.3 Physicochemical and biological properties   D D    
3.2.P.2.3 Manufacturing process development   D D    
3.2.P.2.4 Container Closure System D D D    
3.2.P.2.5 Microbiological attributes   D D    
3.2.P.2.6 Compatibility   D D    
3.2.P.3 Manufacture         2p3-manuf
3.2.P.3.1 Manufacturers D D D   manufacturers
3.2.P.3.2 Batch formula   D D   batch-formula
3.2.P.3.3 Description of manufacturing process and process controls D D D   manuf-process-and-controls
3.2.P.3.4 Control of critical steps and intermediates   D D   control-critical-steps
3.2.P.3.5 Process validation and/or evaluation   D D   process-validation
3.2.P.4 Control of excipients         32p4-contr-excip
3.2.P.4.1 Specifications O D D   specifications
3.2.P.4.2 Analytical procedures O D D   analytical-procedures
3.2.P.4.3 Validation of analytical procedures O D D   validation-analyt-procedures
3.2.P.4.4 Justification of specifications O D D   justification-of-specifications
3.2.P.4.5 Excipients of human or animal origin   D D   excipients-human-animal
3.2.P.4.6 Novel excipients   D D   novel-excipients
3.2.P.5 Control of drug product         32p5-contr-drug-prod
3.2.P.5.1 Specifications O D D   32p51-spec
3.2.P.5.2 Analytical procedures O D D   32p52-analyt-proc
3.2.P.5.3 Validation of analytical procedures O D D   32p53-val-analyt-proc
3.2.P.5.4 Batch analysis   D D   32p54-batch-analys
3.2.P.5.5 Characterisation of impurities and requirements for non-pharmacopoeial products   D D   32p55-charac-imp
3.2.P.5.6 Justification of specifications O D D   32p56-justif-spec
3.2.P.6 Reference standards or materials   D D   32p6-ref-stand
3.2.P.7 Container closure system   D D   32p7-cont-closure-sys
3.2.P.8 Stability   D D   32p8-stab
3.2.P.8.1 Stability summary and conclusion   D D   stability-summary
3.2.P.8.3 Stability data   D D   stability-data
Module Name C1 C2 C3 C4 File or folder name
4 Nonclinical (safety)     D D m4
4.1 Table of contents     D D 41-toc
4.2 Nonclinical study reports     D D 42-stud-rep
4.2.1 Pharmacology     D D 421-pharmacol
4.2.1.1 Primary pharmacodynamics     D D 4211-prim-pd
4.2.1.2 Secondary pharmacodynamics     D D 4212-sec-pd
4.2.1.3 Safety pharmacology     D D 4213-safety-pharmacol
4.2.1.4 Pharmacodynamic drug interactions     D D 4214-pd-drug-interact
4.2.2 Pharmacokinetics     D D 422-pk
4.2.2.1 Analytical methods and validation reports     D D 4221-analyt-met-val
4.2.2.2 Absorption     D D 4222-absorp
4.2.2.3 Distribution     D D 4223-distrib
4.2.2.4 Metabolism     D D 4224-metab
4.2.2.5 Excretion     D D 4225-excr
4.2.2.6 Pharmacokinetic drug interactions     D D 4226-pk-drug-interact
4.2.2.7 Other pharmacokinetic studies     D D 4227-other-pk-stud
4.2.3 Toxicology     D D 423-tox
4.2.3.1 Acute toxicity     D D 4231-acute-tox
4.2.3.2 Repeat dose toxicity     D D 4232-repeat-dose-tox
4.2.3.3 Genotoxicity     D D 4233-genotox
4.2.3.3.1 In vitro     D D 42331-in-vitro
4.2.3.3.2 In vivo     D D 42332-in-vivo
4.2.3.4 Carcinogenicity     D D 4.2.3.4
4.2.3.4.1 Long-term studies     D D 42341-lt-stud
4.2.3.4.2 Short or medium term studies     D D 42342-smt-stud
4.2.3.5 Reproductive and developmental toxicity     D D 4235-repro-dev-tox
4.2.3.5.1 Fertility and early embryonic development     D D 42351-fert-embryo-dev
4.2.3.5.2 Embryo-foetal development     D D embryo-fetal-dev
4.2.3.5.3 Prenatal and postnatal development     D D 42353-pre-postnatal-dev
4.2.3.5.4 Studies in the offspring (juvenile animals are dosed and /or further evaluated)     D D 42354-juv
4.2.3.6 Local tolerance     D D 4236-loc-tol
4.2.3.7 Other toxicity studies     D D 4237-other-tox-stud
4.2.3.7.1 Antigenicity     D D 42371-antigen
4.2.3.7.2 Immunotoxicity     D D 42372-immunotox
4.2.3.7.3 Mechanistic studies     D D 42373-mechan-stud
4.2.3.7.4 Dependence     D D 42374-dep
4.2.3.7.5 Metabolites     D D 42375-metab
4.2.3.7.6 Impurities     D D 42376-imp
4.3 Literature references     D D 43-lit-ref
Module Name C1 C2 C3 C4 File or folder name
5 Clinical         m5
5.1 Table of contents     D D 51-toc
5.2 Tabular listing of all clinical studies     D D 52-tab-list
5.3 Clinical study reports     D D 53-clin-stud-rep
5.3.1 Reports of biopharmaceutic studies     D D 531-rep-biopharm-stud
5.3.2 Reports of studies pertinent to pharmacokinetic using human biomaterials     D D 532-rep-stud-pk-human-biomat
5.3.3 Reports of human pharmacokinetic studies     D D 533-rep-human-pk-stud
5.3.4 Reports of human pharmacodynamic studies     D D 534-rep-human-pd-stud
5.3.5 Reports of efficacy and safety studies (header)     D D 535-rep-effic-safety-stud
5.3.5.1 Study reports of controlled clinical studies pertinent to the claimed indication     D D 5351-stud-rep-contr
5.3.5.2 Study reports of uncontrolled clinical trials     D D 5352-stud-rep-uncontr
5.3.5.3 Reports of analysis of data from more than one study     D D 5353-rep-analys-data-more-one-stud
5.3.5.4 Other clinical study reports     D D 5354-other-stud-rep
5.3.6 Reports of Post-Marketing Experience     D D 536-postmark-exp
5.4 Literature references     D D 54-lit-ref