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← eCTD Controlled Vocabularies

Document type

Classifies the type of a referenced document (e.g. SmPC, labelling, PIL). Used as a keyword on a Context of Use.

eCTD 4.0 Document type 195 terms
All agencies EMA FDA ICH SwissMedic
Term Code Agency Status
Summary of Product Characteristics 100000155532 EMA Active
Annex II 100000155533 EMA Active
Outer Packaging 100000155534 EMA Active
Labelling 100000155535 EMA Active
Immediate Packaging 100000155536 EMA Active
Other Product Information 100000155537 EMA Active
Package Leaflet 100000155538 EMA Active
Combined File of all Documents 100000155539 EMA Active
Mock ups 100000155540 EMA Active
Appendix V 100000155541 EMA Active
Analysis 200000012457 EMA Active
Article 200000012458 EMA Active
Certificate 200000012459 EMA Active
Cytology report 200000012460 EMA Active
Echocardiogram 200000012461 EMA Active
Histopathology report 200000012462 EMA Active
Labeling Materials 200000012463 EMA Active
Laboratory Report 200000012464 EMA Active
Letter 200000012465 EMA Active
Medical Records 200000012466 EMA Active
Necropsy report 200000012467 EMA Active
Other 200000012468 EMA Active
Photograph 200000012469 EMA Active
Product Label 200000012470 EMA Active
QA Report 200000012471 EMA Active
Radiographs 200000012472 EMA Active
Record 200000012473 EMA Active
Sonogram 200000012474 EMA Active
Specification 200000012475 EMA Active
Computer Tomography 200000012476 EMA Active
Investigation report 200000012477 EMA Active
Magnetic Resonance Imaging 200000012478 EMA Active
Multiple document types 200000012479 EMA Active
Promotional Material 200000012480 EMA Active
Package Leaflet and Labelling 200000017121 EMA Active
Specimens 200000027914 EMA Active
List of all authorised presentations (Annex A) 200000027915 EMA Active
Restrictions posed by Member States (Annex 127a) 200000027916 EMA Active
Application Form 200000051362 EMA Active
Tracking Table 200000051363 EMA Active
Application Form Annexes 200000051364 EMA Active
Response 200000051920 EMA Active
Additional data 200000051921 EMA Active
Information for healthcare professionals 756005040000001 SwissMedic —
Patient Information 756005040000002 SwissMedic —
Packaging 756005040000003 SwissMedic —
Basic information for export 756005040000004 SwissMedic —
preclinical study report ich_document_type_1 ICH Active
list patients with batches ich_document_type_10 ICH Active
randomisation scheme ich_document_type_11 ICH Active
audit certificates report ich_document_type_12 ICH Active
statistical methods interim analysis plan ich_document_type_13 ICH Active
inter-laboratory standardisation methods quality assurance ich_document_type_14 ICH Active
publications based on study ich_document_type_15 ICH Active
publications referenced in report ich_document_type_16 ICH Active
discontinued patients ich_document_type_17 ICH Active
protocol deviations ich_document_type_18 ICH Active
patients excluded from efficacy analysis ich_document_type_19 ICH Active
legacy clinical study report ich_document_type_2 ICH Active
demographic data ich_document_type_20 ICH Active
compliance and drug concentration data ich_document_type_21 ICH Active
individual efficacy response data ich_document_type_22 ICH Active
adverse event listings ich_document_type_23 ICH Active
listing individual laboratory measurements by patient ich_document_type_24 ICH Active
case report forms ich_document_type_25 ICH Active
available on request ich_document_type_26 ICH Active
assay validation ich_document_type_27 ICH Active
biomarkers ich_document_type_28 ICH Active
data monitoring review committees ich_document_type_29 ICH Active
synopsis ich_document_type_3 ICH Active
device information ich_document_type_30 ICH Active
diagnostic tests ich_document_type_31 ICH Active
gene therapy ich_document_type_32 ICH Active
patient reported outcomes ich_document_type_33 ICH Active
pharmacodynamics ich_document_type_34 ICH Active
pharmacogenomics ich_document_type_35 ICH Active
pharmacokinetics ich_document_type_36 ICH Active
quality of life ich_document_type_37 ICH Active
stem cells ich_document_type_38 ICH Active
abuse liability ich_document_type_39 ICH Active
study report body ich_document_type_4 ICH Active
antibody ich_document_type_40 ICH Active
healthcare utilization ich_document_type_41 ICH Active
other data not specified ich_document_type_42 ICH Active
pk/pd relationship ich_document_type_43 ICH Active
specialty report ich_document_type_44 ICH Active
bimo ich_document_type_45 ICH Active
foreign clinical studies not under ind ich_document_type_46 ICH Active
data tabulation dataset legacy ich_document_type_47 ICH Active
data tabulation data definition ich_document_type_48 ICH Active
data listing dataset ich_document_type_49 ICH Active
protocol or amendment ich_document_type_5 ICH Active
data listing data definition ich_document_type_50 ICH Active
analysis dataset legacy ich_document_type_51 ICH Active
analysis program ich_document_type_52 ICH Active
analysis data definition ich_document_type_53 ICH Active
annotated crf ich_document_type_54 ICH Active
ecg ich_document_type_55 ICH Active
image ich_document_type_56 ICH Active
subject profiles ich_document_type_57 ICH Active
safety report ich_document_type_58 ICH Active
antibacterial ich_document_type_59 ICH Active
sample case report form ich_document_type_6 ICH Active
special pathogen ich_document_type_60 ICH Active
antiviral ich_document_type_61 ICH Active
iss ich_document_type_62 ICH Active
ise ich_document_type_63 ICH Active
pm description ich_document_type_64 ICH Active
study data reviewer's guide ich_document_type_66 ICH Active
analysis data reviewer's guide ich_document_type_67 ICH Active
hf validation protocol ich_document_type_68 ICH Active
hf validation report ich_document_type_69 ICH Active
iec irb consent form list ich_document_type_7 ICH Active
hf validation other ich_document_type_70 ICH Active
data tabulation dataset sdtm ich_document_type_71 ICH Active
data tabulation dataset send ich_document_type_72 ICH Active
analysis dataset adam ich_document_type_73 ICH Active
csr other ich_document_type_74 ICH Active
hepatic impairment study? ich_document_type_75 ICH Active
renal impairment study? ich_document_type_76 ICH Active
drug-drug interaction study? ich_document_type_77 ICH Active
mass balance study? ich_document_type_78 ICH Active
population pk report? ich_document_type_79 ICH Active
list description investigator site ich_document_type_8 ICH Active
population pkpd report? ich_document_type_80 ICH Active
pbpk report? ich_document_type_81 ICH Active
pbbm report? ich_document_type_82 ICH Active
qsp report? ich_document_type_83 ICH Active
cp general? ich_document_type_84 ICH Active
qt clinical study? ich_document_type_85 ICH Active
qt invitro study? ich_document_type_86 ICH Active
pd invivo study? ich_document_type_87 ICH Active
pd invitro study? ich_document_type_88 ICH Active
iscp? ich_document_type_89 ICH Active
signatures investigators ich_document_type_9 ICH Active
isi? ich_document_type_90 ICH Active
weight of evidence? ich_document_type_91 ICH Active
animal rule efficacy? ich_document_type_92 ICH Active
animal rule natural history? ich_document_type_93 ICH Active
nonstandard safety study? ich_document_type_94 ICH Active
Promotional 2253 us_promo_document_type_1 FDA —
Request For Advisory Launch us_promo_document_type_2 FDA —
Request For Advisory Non-Launch us_promo_document_type_3 FDA —
Presubmission Accelerated Launch us_promo_document_type_4 FDA —
Presubmission Accelerated Non-launch us_promo_document_type_5 FDA —
Pre-Dissemination Review of Television Ads us_promo_document_type_6 FDA —
Consumer us_promo_material_audience_type_1 FDA —
Professional us_promo_material_audience_type_2 FDA —
Audio us_promo_material_type_1 FDA —
File Card us_promo_material_type_10 FDA —
Formulary Economic us_promo_material_type_11 FDA —
Formulary Kit us_promo_material_type_12 FDA —
Giveaway us_promo_material_type_13 FDA —
House Organ us_promo_material_type_14 FDA —
Kit us_promo_material_type_15 FDA —
Monograph us_promo_material_type_16 FDA —
Other us_promo_material_type_17 FDA —
Press Release us_promo_material_type_18 FDA —
Print Ad us_promo_material_type_19 FDA —
Book us_promo_material_type_2 FDA —
Print Other us_promo_material_type_20 FDA —
Promotional Labeling us_promo_material_type_21 FDA —
Radio us_promo_material_type_22 FDA —
Reply Card us_promo_material_type_23 FDA —
Reprint us_promo_material_type_24 FDA —
Sales Aid us_promo_material_type_25 FDA —
Slides us_promo_material_type_26 FDA —
Telephone us_promo_material_type_27 FDA —
TV us_promo_material_type_28 FDA —
Video News Release us_promo_material_type_29 FDA —
Carrier us_promo_material_type_3 FDA —
Video us_promo_material_type_30 FDA —
www-banner us_promo_material_type_31 FDA —
www-ecomm us_promo_material_type_32 FDA —
www-links us_promo_material_type_33 FDA —
www-other us_promo_material_type_34 FDA —
www-soc-med us_promo_material_type_35 FDA —
www-website us_promo_material_type_36 FDA —
www-video us_promo_material_type_37 FDA —
www-mobile us_promo_material_type_38 FDA —
Corrective Internet us_promo_material_type_39 FDA —
Carton us_promo_material_type_4 FDA —
Corrective Letter us_promo_material_type_40 FDA —
Corrective Print Ad us_promo_material_type_41 FDA —
Corrective TV us_promo_material_type_42 FDA —
Electronic Detail Aid us_promo_material_type_43 FDA —
Form us_promo_material_type_44 FDA —
Training Materials us_promo_material_type_45 FDA —
www-audio us_promo_material_type_46 FDA —
PDURS us_promo_material_type_47 FDA —
Catalog us_promo_material_type_5 FDA —
CD-ROM us_promo_material_type_6 FDA —
Direct Mail us_promo_material_type_7 FDA —
Drug Sample us_promo_material_type_8 FDA —
Exhibit us_promo_material_type_9 FDA —

195 terms shown across all authorities. Data sourced from public health authority publications and updated periodically.