R RegData
← eCTD Controlled Vocabularies

Context of Use

Links a CTD table-of-contents heading to the document(s) placed under it. Module 1 codes are regionally defined; Modules 2-5 are ICH-defined.

eCTD 4.0 Context of Use 380 terms
All agencies EMA FDA ICH SwissMedic
Term Code Agency Status
M1.0 Cover Letter and Tracking Table 100000164029 EMA Active
M1.2 Application Form 100000164030 EMA Active
M1.3.1 SmPC, Labeling, Package Leaflet 100000164032 EMA Active
M1.3.2 Mockup 100000164033 EMA Active
M1.3.3 Specimen 100000164034 EMA Active
M1.3.4 Report on Consultation Patient Target Group 100000164035 EMA Active
M1.3.5 Approved Product Information 100000164036 EMA Active
M1.3.6 Braille 100000164037 EMA Active
M1.4.1 Expert on Quality 100000164039 EMA Active
M1.4.2 Expert on Non-Clinical 100000164040 EMA Active
M1.4.3 Expert on Clinical 100000164041 EMA Active
M1.5.1 Bibliographic 100000164043 EMA Active
M1.5.2 Generic, Hybrid or Biosimilar 100000164044 EMA Active
M1.5.3 Data on Market Exclusivity 100000164045 EMA Active
M1.5.4 Exceptional Circumstances 100000164046 EMA Active
M1.5.5 Conditional Approval 100000164047 EMA Active
M1.6.1 Non-Genetically Modified Organisms 100000164049 EMA Active
M1.6.2 Genetically Modified Organisms 100000164050 EMA Active
M1.7.1 Similarity 100000164052 EMA Active
M1.7.2 Market Exclusivity 100000164053 EMA Active
M1.8.1 Pharmacovigilance System 100000164055 EMA Active
M1.8.2 Risk Management System 100000164056 EMA Active
M1.9 Information Relating to Clinical Trials 100000164057 EMA Active
M1.10 Information Relating to Paediatrics 100000164058 EMA Active
M1.R Responses 100000164059 EMA Active
M1.A Additional Data 100000164060 EMA Active
M1 CH Regional Information 110001 SwissMedic —
M1.0 Cover Letter 110002 SwissMedic —
M1.2 Application for Marketing Authorisation and Variation 110003 SwissMedic —
M1.2.1 Form - Application 110004 SwissMedic —
M1.2.2 Forms - Additional 110005 SwissMedic —
M1.2.2.1 Form Full Declaration 110006 SwissMedic —
M1.2.2.2 Form Manufacturer Information 110007 SwissMedic —
M1.2.2.3 Form Status Marketing Authorisations Abroad 110008 SwissMedic —
1.2.2.4++ 110009 SwissMedic —
1.2.2.5++ 110010 SwissMedic —
1.2.2.6++ 110011 SwissMedic —
1.2.2.7++ 110012 SwissMedic —
M1.2.2.8 Form Substances of Animal or Human Origin 110013 SwissMedic —
1.2.2.9++ 110014 SwissMedic —
1.2.2.10++ 110015 SwissMedic —
1.2.2.11++ 110016 SwissMedic —
1.2.2.12++ 110017 SwissMedic —
M1.2.2.13 Form Change of Marketing Authorisation Holder 110018 SwissMedic —
1.2.2.14++ 110019 SwissMedic —
.2.2.15++ 110020 SwissMedic —
M1.2.2.16 Form PSUR/PBRER for Human Medicines 110021 SwissMedic —
M1.2.2.17 Form Declaration Radiopharmaceuticals 110022 SwissMedic —
M1.2.2.18 Form Confirmation Regarding Substances from GMO 110023 SwissMedic —
M1.2.2.19 Form DMF 110024 SwissMedic —
M1.2.2.20 Form Information Relating to Applications under Art. 13 TPA 110025 SwissMedic —
1.2.2.21++ 110026 SwissMedic —
1.2.2.22++ 110027 SwissMedic —
M1.2.2.23 Form Application for Recognition of Orphan Drug Status 110028 SwissMedic —
1.2.2.24++ 110029 SwissMedic —
M1.2.2.25 Form PIP 110030 SwissMedic —
M1.2.2.26 GCP Inspections 110031 SwissMedic —
M1.2.2.99 Other Forms [extensional sections allowed] 110032 SwissMedic —
M1.2.3 Annexes - Documents on Drug Quality 110033 SwissMedic —
M1.2.3.1 DMF Letter of Access 110034 SwissMedic —
M1.2.3.2 Ph. Eur. Certificate of Suitability for Active Substance 110035 SwissMedic —
M1.2.3.3 Ph. Eur. Certificate of Suitability for TSE 110036 SwissMedic —
M1.2.3.4 EMA Certificate for Plasma Master File (PMF) 110037 SwissMedic —
M1.2.3.5 EMA Certificate for Vaccine Antigen Master File (VAMF) 110038 SwissMedic —
M1.2.4 Annexes – Manufacturing 110039 SwissMedic —
M1.2.4.1 GMP Certificate or Other GMP Documents 110040 SwissMedic —
M1.2.4.2 Documentation Concerning Manufacturing Authorisation 110041 SwissMedic —
M1.2.4.3 Complete Manufacturing Information with Flow Chart 110042 SwissMedic —
M1.2.4.4 Confirmation on GMP Conformity 110043 SwissMedic —
M1.2.5 Annexes – Others 110044 SwissMedic —
M1.2.5.1 Comparison of Approved Information for Professionals with EU SmPC (for PSURs) 110045 SwissMedic —
M1.2.5.2 Company Core Data Sheet (for PSURs) 110046 SwissMedic —
M1.3 Product Information and Packaging Material 110047 SwissMedic —
M1.3.1 Information for Professionals 110048 SwissMedic —
M1.3.2 Patient Information 110049 SwissMedic —
M1.3.3 Packaging Information 110050 SwissMedic —
M1.3.4 Information for Professionals from Other Countries 110051 SwissMedic —
M1.4 Information About the Expert 110052 SwissMedic —
M1.4.1 Quality 110053 SwissMedic —
M1.4.2 Nonclinical 110054 SwissMedic —
M1.4.3 Clinical 110055 SwissMedic —
M1.5 Data of Bioavailability Studies (Known Active Substance without Innovation) 110056 SwissMedic —
M1.5.1 Information according to Appendix IV of the Guideline on the Investigation on Bioequivalence 110057 SwissMedic —
M1.5.2 Documents on the Reference Product 110058 SwissMedic —
1.5.3++ 110059 SwissMedic —
M1.5.4 Art 14 Sec1 let abis TPA tabular compilation of deviations between product to be authorised in CH and foreign comparator 110060 SwissMedic —
M1.6 Environmental Risk Assessment 110061 SwissMedic —
M1.6.1 Non-GMO 110062 SwissMedic —
M1.6.2 GMO 110063 SwissMedic —
M1.7 Decisions of Foreign Authorities 110064 SwissMedic —
M1.7.1 Responses to LoQ 110065 SwissMedic —
M1.7.2 Assessment Report 110066 SwissMedic —
M1.7.3 EU Decision 110067 SwissMedic —
M1.7.4 FDA Decision 110068 SwissMedic —
M1.7.5 Decisions of Other Foreign Authorities 110069 SwissMedic —
M1.7.6 Article 13 TPA Additional Documentation 110070 SwissMedic —
M1.8 Information Relating to Pharmacovigilance 110071 SwissMedic —
M1.8.1 Pharmacovigilance System 110072 SwissMedic —
M1.8.2 Risk-Management System 110073 SwissMedic —
M1.9 Fast Track Status Decision 110074 SwissMedic —
M1.10 Information Relating to Paediatrics 110075 SwissMedic —
M1.11 Orphan Drug Status Decision 110076 SwissMedic —
M1.12 Art 14 Sec 1 let abis-quater TPA Documents 110077 SwissMedic —
M1.12.1 Proof of 10 Years EU/EFTA Authorisation 110078 SwissMedic —
1.12.2++ 110079 SwissMedic —
M1.12.3 Proof of 30 Years Overall Medical Use - 15 Years Medical Use EU/EFTA 110080 SwissMedic —
M1.12.4 Proof of 15 Years Cantonal Authorisation 110081 SwissMedic —
Responses to Swissmedic LoQ 110082 SwissMedic —
Additional Information 110083 SwissMedic —
current active ICH Active
m2 common technical document summaries ich_2 ICH Active
m2.2 introduction ich_2.2 ICH Active
m2.3 quality overall summary ich_2.3 ICH Active
m2.3.a.1 facilities and equipment ich_2.3.a.1 ICH Active
m2.3.a.2 adventitious agents safety evaluation ich_2.3.a.2 ICH Active
m2.3.a.3 excipients ich_2.3.a.3 ICH Active
m2.3.i introduction ich_2.3.i ICH Active
m2.3.p drug product ich_2.3.p ICH Active
m2.3.r regional information ich_2.3.r ICH Active
m2.3.s drug substance ich_2.3.s ICH Active
m2.4 nonclinical overview ich_2.4 ICH Active
m2.5 clinical overview ich_2.5 ICH Active
m2.6.1 introduction ich_2.6.1 ICH Active
m2.6.2 pharmacology written summary ich_2.6.2 ICH Active
m2.6.3 pharmacology tabulated summary ich_2.6.3 ICH Active
m2.6.4 pharmacokinetics written summary ich_2.6.4 ICH Active
m2.6.5 pharmacokinetics tabulated summary ich_2.6.5 ICH Active
m2.6.6 toxicology written summary ich_2.6.6 ICH Active
m2.6.7 toxicology tabulated summary ich_2.6.7 ICH Active
m2.7.1 summary of biopharmaceutic studies and associated analytical methods ich_2.7.1 ICH Active
m2.7.2 summary of clinical pharmacology studies ich_2.7.2 ICH Active
m2.7.3 summary of clinical efficacy ich_2.7.3 ICH Active
m2.7.4 summary of clinical safety ich_2.7.4 ICH Active
m2.7.5 literature references ich_2.7.5 ICH Active
m2.7.6 synopses of individual studies ich_2.7.6 ICH Active
m3.2.a appendices ich_3.2.a ICH Active
m3.2.a.1 facilities and equipment ich_3.2.a.1 ICH Active
m3.2.a.2 adventitious agents safety evaluation ich_3.2.a.2 ICH Active
m3.2.a.3 excipients ich_3.2.a.3 ICH Active
m3.2.p drug product ich_3.2.p ICH Active
m3.2.p.1 description and composition of the drug product ich_3.2.p.1 ICH Active
m3.2.p.2 pharmaceutical development ich_3.2.p.2 ICH Active
m3.2.p.2.1 components of the drug product ich_3.2.p.2.1 ICH Active
m3.2.p.2.2 drug product ich_3.2.p.2.2 ICH Active
m3.2.p.2.3 manufacturing process development ich_3.2.p.2.3 ICH Active
m3.2.p.2.4 container closure system ich_3.2.p.2.4 ICH Active
m3.2.p.2.5 microbiological attributes ich_3.2.p.2.5 ICH Active
m3.2.p.2.6 compatibility ich_3.2.p.2.6 ICH Active
m3.2.p.3 manufacture ich_3.2.p.3 ICH Active
m3.2.p.3.1 manufacturer(s) ich_3.2.p.3.1 ICH Active
m3.2.p.3.2 batch formula ich_3.2.p.3.2 ICH Active
m3.2.p.3.3 description of manufacturing process and process controls ich_3.2.p.3.3 ICH Active
m3.2.p.3.4 controls of critical steps and intermediates ich_3.2.p.3.4 ICH Active
m3.2.p.3.5 process validation and/or evaluation ich_3.2.p.3.5 ICH Active
m3.2.p.4 control of excipients ich_3.2.p.4 ICH Active
m3.2.p.4.1 specifications ich_3.2.p.4.1 ICH Active
m3.2.p.4.2 analytical procedures ich_3.2.p.4.2 ICH Active
m3.2.p.4.3 validation of analytical procedures ich_3.2.p.4.3 ICH Active
m3.2.p.4.4 justification of specifications ich_3.2.p.4.4 ICH Active
m3.2.p.4.5 excipients of human or animal origin ich_3.2.p.4.5 ICH Active
m3.2.p.4.6 novel excipients ich_3.2.p.4.6 ICH Active
m3.2.p.5 control of drug product ich_3.2.p.5 ICH Active
m3.2.p.5.1 specification(s) ich_3.2.p.5.1 ICH Active
m3.2.p.5.2 analytical procedures ich_3.2.p.5.2 ICH Active
m3.2.p.5.3 validation of analytical procedures ich_3.2.p.5.3 ICH Active
m3.2.p.5.4 batch analyses ich_3.2.p.5.4 ICH Active
m3.2.p.5.5 characterisation of impurities ich_3.2.p.5.5 ICH Active
m3.2.p.5.6 justification of specifications ich_3.2.p.5.6 ICH Active
m3.2.p.6 reference standards or materials ich_3.2.p.6 ICH Active
m3.2.p.7 container closure system ich_3.2.p.7 ICH Active
m3.2.p.8 stability ich_3.2.p.8 ICH Active
m3.2.p.8.1 stability summary and conclusion ich_3.2.p.8.1 ICH Active
m3.2.p.8.2 post-approval stability protocol and stability commitment ich_3.2.p.8.2 ICH Active
m3.2.p.8.3 stability data ich_3.2.p.8.3 ICH Active
m3.2 r regional information ich_3.2.r ICH Active
m3.2.s drug substance ich_3.2.s ICH Active
m3.2.s.1 general information ich_3.2.s.1 ICH Active
m3.2.s.2 manufacture ich_3.2.s.2 ICH Active
m3.2.s.2.1 manufacturer(s) ich_3.2.s.2.1 ICH Active
m3.2.s.2.2 description of manufacturing process and process controls ich_3.2.s.2.2 ICH Active
m3.2.s.2.3 control of materials ich_3.2.s.2.3 ICH Active
m3.2.s.2.4 controls of critical steps and intermediates ich_3.2.s.2.4 ICH Active
m3.2.s.2.5 process validation and/or evaluation ich_3.2.s.2.5 ICH Active
m3.2.s.2.6 manufacturing process development ich_3.2.s.2.6 ICH Active
m3.2.s.3 characterisation ich_3.2.s.3 ICH Active
m3.2.s.3.1 elucidation of structure and other characteristics ich_3.2.s.3.1 ICH Active
m3.2.s.3.2 impurities ich_3.2.s.3.2 ICH Active
m3.2.s.4 control of drug substance ich_3.2.s.4 ICH Active
m3.2.s.4.1 specification ich_3.2.s.4.1 ICH Active
m3.2.s.4.2 analytical procedures ich_3.2.s.4.2 ICH Active
m3.2.s.4.3 validation of analytical procedures ich_3.2.s.4.3 ICH Active
m3.2.s.4.4 batch analyses ich_3.2.s.4.4 ICH Active
m3.2.s.4.5 justification of specification ich_3.2.s.4.5 ICH Active
m3.2.s.5 reference standards or materials ich_3.2.s.5 ICH Active
m3.2.s.6 container closure system ich_3.2.s.6 ICH Active
m3.2.s.7 stability ich_3.2.s.7 ICH Active
m3.2.s.7.1 stability summary and conclusions ich_3.2.s.7.1 ICH Active
m3.2.s.7.2 post-approval stability protocol and stability commitment ich_3.2.s.7.2 ICH Active
m3.2.s.7.3 stability data ich_3.2.s.7.3 ICH Active
m3.3 literature references ich_3.3 ICH Active
m4.2.1.1 primary pharmacodynamics ich_4.2.1.1 ICH Active
m4.2.1.2 secondary pharmacodynamics ich_4.2.1.2 ICH Active
m4.2.1.3 safety pharmacology ich_4.2.1.3 ICH Active
m4.2.1.4 pharmacodynamic drug interactions ich_4.2.1.4 ICH Active
m4.2.2.1 analytical methods and validation reports ich_4.2.2.1 ICH Active
m4.2.2 2 absorption ich_4.2.2.2 ICH Active
m4.2.2.3 distribution ich_4.2.2.3 ICH Active
m4.2.2.4 metabolism ich_4.2.2.4 ICH Active
m4.2.2.5 excretion ich_4.2.2.5 ICH Active
m4.2.2.6 pharmacokinetic drug interactions ich_4.2.2.6 ICH Active
m4.2.2.7 other pharmacokinetic studies ich_4.2.2.7 ICH Active
m4.2.3.1 single-dose toxicity ich_4.2.3.1 ICH Active
m4.2.3.2 repeat-dose toxicity ich_4.2.3.2 ICH Active
m4.2.3.3.1 in vitro ich_4.2.3.3.1 ICH Active
m4.2.3.3.2 in vivo ich_4.2.3.3.2 ICH Active
m4.2.3.4.1 long-term studies ich_4.2.3.4.1 ICH Active
m4.2.3.4.2 short or medium-term studies ich_4.2.3.4.2 ICH Active
m4.2.3.4.3 other studies ich_4.2.3.4.3 ICH Active
m4.2.3.5.1 fertility and early embryonic development ich_4.2.3.5.1 ICH Active
m4.2.3.5.2 embryofetal development ich_4.2.3.5.2 ICH Active
m4.2.3.5.3 prenatal and postnatal development, including maternal function ich_4.2.3.5.3 ICH Active
m4.2.3.5.4 studies in which the offspring juvenile animals are dosed and/or further evaluated ich_4.2.3.5.4 ICH Active
m4.2.3.6 local tolerance ich_4.2.3.6 ICH Active
m4.2.3.7.1 antigenicity ich_4.2.3.7.1 ICH Active
m4.2.3.7.2 immunotoxicity ich_4.2.3.7.2 ICH Active
m4.2.3.7.3 mechanistic studies ich_4.2.3.7.3 ICH Active
m4.2.3.7.4 dependence ich_4.2.3.7.4 ICH Active
m4.2.3.7.5 metabolites ich_4.2.3.7.5 ICH Active
m4.2.3.7.6 impurities ich_4.2.3.7.6 ICH Active
m4.2.3.7.7 other ich_4.2.3.7.7 ICH Active
m4.3 literature references ich_4.3 ICH Active
m5.2 tabular listing of all clinical studies ich_5.2 ICH Active
m5.3.1.1 bioavailability study reports ich_5.3.1.1 ICH Active
m5.3.1.2 comparative ba and bioequivalence study reports ich_5.3.1.2 ICH Active
m5.3.1.3 in vitro in vivo correlation study reports ich_5.3.1.3 ICH Active
m5.3.1.4 reports of bioanalytical and analytical methods for human studies ich_5.3.1.4 ICH Active
m5.3.2.1 plasma protein binding study reports ich_5.3.2.1 ICH Active
m5.3.2.2 reports of hepatic metabolism and drug interaction studies ich_5.3.2.2 ICH Active
m5.3.2.3 reports of studies using other human biomaterials ich_5.3.2.3 ICH Active
m5.3.3.1 healthy subject pk and initial tolerability study reports ich_5.3.3.1 ICH Active
m5.3.3.2 patient pk and initial tolerability study reports ich_5.3.3.2 ICH Active
m5.3.3 3 intrinsic factor pk study reports ich_5.3.3.3 ICH Active
m5.3.3.4 extrinsic factor pk study reports ich_5.3.3.4 ICH Active
m5.3.3.5 population pk study reports ich_5.3.3.5 ICH Active
m5.3.4.1 healthy subject pd and pk/pd study reports ich_5.3.4.1 ICH Active
m5.3.4.2 patient pd and pk/pd study reports ich_5.3.4.2 ICH Active
m5.3.5.1 study reports of controlled clinical studies pertinent to the claimed indication ich_5.3.5.1 ICH Active
m5.3.5.2 study reports of uncontrolled clinical studies ich_5.3.5.2 ICH Active
m5.3.5.3 reports of analyses of data from more than one study ich_5.3.5.3 ICH Active
m5.3.5.4 other study reports ich_5.3.5.4 ICH Active
m5.3.6 reports of postmarketing experience ich_5.3.6 ICH Active
m5.3.7 case report forms and individual patient listings ich_5.3.7 ICH Active
m5.4 literature references ich_5.4 ICH Active
replaced obsolete ICH Active
no longer relevant suspended ICH Active
— us_1.1 FDA —
— us_1.10.1 FDA —
— us_1.10.2 FDA —
— us_1.11.1 FDA —
— us_1.11.2 FDA —
— us_1.11.3 FDA —
— us_1.11.4 FDA —
— us_1.12.1 FDA —
— us_1.12.10 FDA —
— us_1.12.11 FDA —
— us_1.12.12 FDA —
— us_1.12.13 FDA —
— us_1.12.14 FDA —
— us_1.12.15 FDA —
— us_1.12.16 FDA —
— us_1.12.17 FDA —
— us_1.12.18 FDA —
— us_1.12.2 FDA —
— us_1.12.3 FDA —
— us_1.12.4 FDA —
— us_1.12.5 FDA —
— us_1.12.6 FDA —
— us_1.12.7 FDA —
— us_1.12.8 FDA —
— us_1.12.9 FDA —
— us_1.13.1 FDA —
— us_1.13.10 FDA —
— us_1.13.11 FDA —
— us_1.13.12 FDA —
— us_1.13.13 FDA —
— us_1.13.14 FDA —
— us_1.13.15 FDA —
— us_1.13.2 FDA —
— us_1.13.3 FDA —
— us_1.13.4 FDA —
— us_1.13.5 FDA —
— us_1.13.6 FDA —
— us_1.13.7 FDA —
— us_1.13.8 FDA —
— us_1.13.9 FDA —
— us_1.14.1.1 FDA —
— us_1.14.1.2 FDA —
— us_1.14.1.3 FDA —
— us_1.14.1.4 FDA —
— us_1.14.1.5 FDA —
— us_1.14.2.1 FDA —
— us_1.14.2.2 FDA —
— us_1.14.2.3 FDA —
— us_1.14.3.1 FDA —
— us_1.14.3.2 FDA —
— us_1.14.3.3 FDA —
— us_1.14.4.1 FDA —
— us_1.14.4.2 FDA —
— us_1.14.5 FDA —
— us_1.14.6 FDA —
— us_1.15.1.1 FDA —
— us_1.15.1.10 FDA —
— us_1.15.1.11 FDA —
— us_1.15.1.2 FDA —
— us_1.15.1.3 FDA —
— us_1.15.1.4 FDA —
— us_1.15.1.5 FDA —
— us_1.15.1.6 FDA —
— us_1.15.1.7 FDA —
— us_1.15.1.8 FDA —
— us_1.15.1.9 FDA —
— us_1.15.2.1.1 FDA —
— us_1.15.2.1.2 FDA —
— us_1.15.2.1.3 FDA —
— us_1.15.2.1.4 FDA —
— us_1.16.1 FDA —
— us_1.16.2.1 FDA —
— us_1.16.2.2 FDA —
— us_1.16.2.3 FDA —
— us_1.16.2.4 FDA —
— us_1.16.2.5 FDA —
— us_1.16.2.6 FDA —
— us_1.17.1 FDA —
— us_1.17.2 FDA —
— us_1.18.1 FDA —
— us_1.18.2 FDA —
— us_1.19 FDA —
— us_1.2 FDA —
— us_1.20 FDA —
— us_1.3.1.1 FDA —
— us_1.3.1.2 FDA —
— us_1.3.1.3 FDA —
— us_1.3.1.4 FDA —
— us_1.3.1.5 FDA —
— us_1.3.2 FDA —
— us_1.3.3 FDA —
— us_1.3.4 FDA —
— us_1.3.5.1 FDA —
— us_1.3.5.2 FDA —
— us_1.3.5.3 FDA —
— us_1.3.6 FDA —
— us_1.4.1 FDA —
— us_1.4.2 FDA —
— us_1.4.3 FDA —
— us_1.4.4 FDA —
— us_1.5.1 FDA —
— us_1.5.2 FDA —
— us_1.5.3 FDA —
— us_1.5.4 FDA —
— us_1.5.5 FDA —
— us_1.5.6 FDA —
— us_1.5.7 FDA —
— us_1.6.1 FDA —
— us_1.6.2 FDA —
— us_1.6.3 FDA —
— us_1.7.1 FDA —
— us_1.7.2 FDA —
— us_1.7.3 FDA —
— us_1.7.4 FDA —
— us_1.8.1 FDA —
— us_1.8.2 FDA —
— us_1.8.3 FDA —
— us_1.8.4 FDA —
— us_1.9.1 FDA —
— us_1.9.2 FDA —
— us_1.9.3 FDA —
— us_1.9.4 FDA —
— us_1.9.6 FDA —
material-id us_keyword_definition_type_1 FDA —
issue-date us_keyword_definition_type_2 FDA —

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