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1 Supprt Dcumentatin fr M8: ectd EWG ectd v4.0 Implementatin Package v1.2 Internatinal Cuncil fr Harmnisatin f Technical Requirements fr Pharmaceuticals fr Human Use 1

2 Legal Ntice ectd v4.0 Supprt Dcumentatin This presentatin is prtected by cpyright and may be used, reprduced, incrprated int ther wrks, adapted, mdified, translated r distributed under a public license prvided that ICH's cpyright in the presentatin is acknwledged at all times. In case f any adaptin, mdificatin r translatin f the presentatin, reasnable steps must be taken t clearly label, demarcate r therwise identify that changes were made t r based n the riginal presentatin. Any impressin that the adaptin, mdificatin r translatin f the riginal presentatin is endrsed r spnsred by the ICH must be avided. The presentatin is prvided "as is" withut warranty f any kind. In n event shall the ICH r the authrs f the riginal presentatin be liable fr any claim, damages r ther liability arising frm the use f the presentatin. 2

3 Dcument Histry ectd v4.0 Supprt Dcumentatin June 2016 Nvember 2016 First release based n the Implementatin Package v1.1 Updated based n the Implementatin Package v1.2 3

4 Table f Cntents ectd v4.0 Supprt Dcumentatin Intrductin Basics f ectd v4.0 Transitin Mapping Message ICH Validatin Questins, Change Requests Nte: White bx n tp right crner f the fllwing slides indicate crrespnding sectin(s) n the ectd v4.0 Implementatin Package. 4

5 Intrductin Internatinal Cuncil fr Harmnisatin f Technical Requirements fr Pharmaceuticals fr Human Use 5

6 Backgrund ectd v4.0 Supprt Dcumentatin The specificatin fr the ectd is based upn cntent defined within the CTD issued by the ICH M4 EWG. The structure and level f detail specified in the CTD was used t define the ectd structure and cntent, but the CTD did nt describe dcuments that can be submitted as amendments r variatins t the initial applicatin. The ectd was defined as an interface fr Regulated Industry t Regulatry Authrity transfer f regulatry infrmatin while at the same time taking int cnsideratin the facilitatin f the creatin, review, life cycle management and archiving f the electrnic submissin. ectd reached Step 4 in 2003, and with several minr updates, it was implemented in all the ICH regins. A majr versin (v4.0) was added by ICH M8 EWG and reached Step 4 in ectd v4.0 is based n the HL7 RPS R2 Nrmative. 6

7 1. Purpse ectd v4.0 Supprt Dcumentatin Purpse f ectd v4.0 Dcumentatin The ICH ectd v4.0 Implementatin Package (the Package) serves as the implementatin guide and a technical specificatin fr the ectd v4.0 Mdules 2 thrugh 5 using the HL7 V3 RPS R2 Nrmative. Implementers f v4.0 messages are the main audience f these dcuments. Sme files (e.g., schema and genericde files) are fr use in systems i.e., nt human readable. 7

8 2. Scpe ectd v4.0 Scpe ectd v4.0 Supprt Dcumentatin The scpe f the ICH activities cvers the human pharmaceutical prduct marketing apprval prcesses. The Package cvers the specificatin infrmatin fr: ectd v4.0 Mdules 2-5 submissin cntents, and Transitin message mapping between v3.2.2 and v4.0. The Package des NOT cver the specificatin infrmatin fr: The ectd v4.0 Reginal/Mdule 1 cntent, including the Reginal Administrative and Prduct Infrmatin; Transitin message between ther versins; r Hw the tls shuld display ectd v4.0 t the users. The Package defines the message fr exchanging regulatry submissin infrmatin electrnically between Regulatry Authrities and the Pharmaceutical Industry. The ectd v4.0 XML message prvides the ability t describe the cntents f the submissin unit and all infrmatin needed t prcess an individual regulatry exchange between these tw parties. 8

9 3.4 Advantages f ectd v4.0 ectd v4.0 Supprt Dcumentatin Advantages f ectd v4.0 Harmnised submissin unit: All cntent frm Mdule 1 thrugh Mdule 5 is cntained in ne exchange message i.e., an XML file cvers bth ICH and reginal infrmatin. Dcument reuse: Once a dcument has been submitted, ectd v4.0 will allw fr the dcument t be reused by referencing its unique ID frm the same r different submissin unit. All the cntents f the reused dcument, including references and hypertext links t ther dcuments, shuld be relevant t the submissin that reuses the dcument. Cntext f Use life cycle: The Cntext f Use cncept allws fr advanced life cycle management peratins. A Cntext f Use may be replaced by ne r mre Cntext f Use elements and vice versa (i.e., many t ne) thrugh the cntext f use life cycle. ectd v4.0 als intrduces the ability t apply changes t keywrd definitin display name values (e.g., drug substance/prduct names, manufacturers, dsage frms, indicatin, excipient, grup title, etc.) withut resubmitting the physical files r the Cntexts f Use element. Functin f cntext grups: The Cntext f Use cde and Keywrd cde cmbinatin will functin t create a grup f dcuments in a specific cntext. One use f cntext grups includes the replacement fr STFs in Mdules 4 and 5 t rganise 9 multiple files relating t a single clinical study as nted in the ectd specificatin v3.2.2.

10 4. Cmpnents f the ectd v4.0 ectd v4.0 Supprt Dcumentatin ectd v4.0 Implementatin Package The fllwing figure utlines the dcuments in the implementatin package (zip file): ICH_eCTDv4_0_ImplementatinPackage_v1_2.zip ectd v4_0_implementatin_package_histry_v1_2.pdf Package Histry ICH_eCTDv3_2_2TMM_CVv1_2.xlsx ICH_eCTDv4_0_CVv1_2.xlsx ICH CV "ICH_eCTDv3_2_2TMM_CVv1_2.xlsx" is a list f CV t be used in Transitin Mapping Messages. "ICH_eCTDv4_0_CVv1_2.xlsx" is a list f CV t be used in ectd v4.0 Messages. ICH_eCTDv4_0_ImplementatinGuide_v1_2pdf ICH IG Genericde ICH Genericde ectd_v4_schemafiles Schema 10

11 4. Cmpnents f the ectd v4.0 ectd v4.0 Supprt Dcumentatin Cmpnents f the ectd v4.0 SDO HL7 RPS R2 Schema Data Type Reference Define specificatins ICH Implementatin Package ICH Genericde ICH M8 = ICH CV OID ectd XML OID UUID Reginal CV OID Regin ICH IG Data Type Validatin Rules Reginal/ Mdule 1 Implementatin Guide. Data Type ICH SSF 11

12 4. Cmpnents f the ectd v4.0 ectd v4.0 Supprt Dcumentatin ectd v4.0 Cmpnents Cmpnents Schema Data Type ICH IG (Implementatin Guide) ICH CV (Cntrlled Vcabularies) ICH Genericde Validatin Rules OID (Object Identifier) UUID (Universal Unique Identifier) ICH SSF (Specificatin fr Submissin Frmat) Reginal/Mdule 1 Implementatin Guide Reginal CV Descriptin Defines the basic XML elements and attributes t be used in ectd v4.0 XML messages. Since the schema was develped by HL7 and is nt nly fr ICH ectd v4.0, the users als needs t refer ICH IG fr detailed instructins specific fr ICH ectd v4.0. Defines the type f value per element r attribute. Basic data types are defined by the HL7, but ICH IG r Reginal Guidance culd cnstrain them. Examples culd be alpha, numeric, and etc. Technical specificatin fr the ectd v4.0 Mdules 2 thrugh 5 using the HL7 V3 RPS R2 Nrmative. ectd v4.0 messages must fllw this dcument. Defines the valid values t be used fr the infrmatin exchanged by the ectd v4.0 XML Messages r Transitin Mapping Messages. Cmputer-readable frmat f the ICH CV. Defines the criteria which the ectd v4.0 are validated against. The ICH IG cntains the rules that all the ICH regins reject submissin unit if it vilates. Reginal/Mdule 1 Implementatin Guide culd prvide mre detailed rules. Identifies the cde lists n which the cdes are defined. The cde list culd be wned by ICH, reginal authrity, r applicant. Identifies the instances submitted by ectd v4.0. Fr example, submissin unit, submissin, applicatin, dcument, and etc. are all submitted with UUID. Defines technical specificatin f the files exchanged by ectd. The SSF is nt nly fr v4.0, but it applies t all the versins f ectd. Technical Specificatin fr implementatin f ectd v4.0 in the regin. It gives detailed instructins that apply t the regin in additin t the ICH IG and SSF. Defines the valid values t be used fr the infrmatin exchanged by the ectd v4.0 XML messages 12in the regin.

13 ectd v4.0 Supprt Dcumentatin ectd v4.0 Implementatin Package Change Cntrl Changes t the Implementatin Package will be made as necessary, and may relate t any f the v4.0 cmpnents. Minr changes will be cnsidered thse that may change the implementatin rules and vcabulary, but nt a change t the schema. Majr changes will be cnsidered thse that require changes t the schema files, alng with assciated implementatin rules and vcabulary changes. See Slide #14 fr Change Request infrmatin. 13

14 3.5 Change Cntrl Change Cntrl ectd v4.0 Supprt Dcumentatin Questin r Change Request Standard ICH Dcument Q&A Dcument ICH Stakehlders ICH M8 EWG/IWG SDO Stakehlders SDO Start Start Submit Questin r Change Request t ICH Dcument Evaluate Questin r Change Request Nte: Submit the Questin r Change Request t the M8 representative f the party/regin. Need SDO Standard update? N Yes Submit Questin r Change Request t SDO Nte: ICH can be the SDO stakehlder SDO Change Cntrl Prcess Thse nt residing in an ICH regin can frward this request t the M8 Rapprteur r t the ICH Secretariat (admin@ich.rg) N Need ICH Dcument update? Update the standard Yes Update ICH Dcument Nte: If the SDO evaluates the standard desn't need t be updated, the SDO takes its prcess fr nt updating the standard Update and pst Q&A Dcument 14

15 ectd v4.0 Supprt Dcumentatin 4.7 Reginal/Mdule 1 Implementatin Guides Reginal/Mdule 1 Implementatin Guides The Reginal/Mdule 1 Implementatin Guides play a key rle in prviding the administrative infrmatin. The administrative infrmatin in the message is mainly fund in Mdule 1 and, as such, is the main subject f the Reginal/Mdule 1 Implementatin. Nte t the Implementers The infrmatin in this ICH ectd v4.0 Implementatin Guide is necessary, but nt sufficient fr creating the cmplete XML message fr transmissin. The Reginal/Mdule 1 Implementatin Guides are required t send a cmplete XML message. The Reginal/Mdule 1 Implementatin Guides will be available thrugh the ICH ESTRI website. 15

16 ectd v4.0 Supprt Dcumentatin Excluded Business Prcesses Excluded Business Prcesses The ICH dcuments will nt address any reginal business prcesses. The reginal business prcess(es) may include, but are nt limited t the fllwing: Tw-way Cmmunicatin - includes infrmatin n Regulatry Authrity cmmunicatin with the Applicant. Dssier Management/Submissin Life Cycle - includes rules fr Submissin Unit, Submissin and Applicatins. Submissin Units with Multiple Submissin cmpnents (e.g., Gruped Submissins and Gruped Variatins) - includes rules fr sending submissin units that will reference mre than ne submissin cmpnent. Refer t Reginal/Mdule 1 Implementatin Guides fr additinal infrmatin abut Regin/Cuntry specific excluded business prcesses. 16

17 Basics f the ectd v4.0 Submissin Unit (including the XML Message and Submissin Cntents) and assciated dcumentatin Internatinal Cuncil fr Harmnisatin f Technical Requirements fr Pharmaceuticals fr Human Use 17

18 ectd v4.0 Supprt Dcumentatin ectd v4.0 Submissin Unit The ectd v4.0 Submissin Unit cntains: submissinunit.xml One ectd v4.0 Message includes bth cntent frm Reginal/Mdule 1 and Mdule 2 5. Refer t Sectin 5.1. sha256.txt Checksum fr the submissinunit.xml file Replaces md5.txt files Refer t Sectin 5.1 Flders and Files Cntain the flder structure and files fr the cntents included in the XML message. Refer t Sectins 4.1, 5 and 11 (Appendix 1). 18

19 ectd v4.0 Supprt Dcumentatin ICH ectd v4.0 Submissin Unit Big Picture f Message Applicant submits Submissin Units t Regulatr. A Submissin Unit has the infrmatin abut the Submissin and Applicatin t which it belngs. Applicant Regulatr ICH ectd v4.0 Message Applicatin Applicatin Submissin Submissin Unit Submissin Unit Submissin Unit Submissin Applicatin Submissin Submissin Unit Submissin Unit Nte: Tw-way cmmunicatin is excluded frm ICH business cases. 19

20 ectd v4.0 Supprt Dcumentatin ICH ectd v4.0 Hierarchical Structure 3-layered hierarchy - A Submissin Unit belngs t a Submissin, and a Submissin belngs t an Applicatin. Submissin Unit - Als knwn as sequence Includes the assignment f a sequence number. - Applicants submit a Submissin Unit t regulatr. - Culd belng t multiple Submissins (e.g., Gruped submissins in sme regins). Submissin - Hlds ne r many Submissin Units. - Each regin defines the rules fr this element. Applicatin - Hlds ne r many Submissins. - Each regin defines the rules fr this element. 20

21 ectd v4.0 Supprt Dcumentatin 5. Submissin Cntents, Flder and File Structure Submissin Cntents, Flder and File Structure Flder name is determined by the regin. ectd XML OID UUID Flder name is the sequence number (e.g., "1", "2", etc.). File name shuld be "sha256.txt". SHA-256 checksum value is given as the bdy f text file. File name shuld be "submissinunit.xml". Refer t the ICH IG and Reginal/Mdule 1 Implementatin Guide. Structure f m1 flder shuld fllw Reginal/Mdule 1 Implementatin Guide. Structure f m2-m5 flders shuld fllw ICH IG. All files included in these flders shuld be accunted fr in the XML message. Files previusly sent d nt need t be sent again. N schema file shuld be submitted. 21

22 4.5 OIDs and UUIDs ectd v4.0 Supprt Dcumentatin ectd v4.0 XML Message Basics - Identifiers 2 types f identifiers OID (Object Identifier) - Identifies the cde lists n which the cdes are defined. The cde list culd be wned by ICH, reginal authrity, r applicant. - Given as a value fr cdesystem attribute f cde element. - Human-readable fr thse wh understand the numbers. - Example: <cde cde="ich_2.5" cdesystem=" "/> ID rt - Uniquely identifies the instance. - Given as a value fr rt attribute f id element. - Universally Unique Identifier ( characters; each number is hexadecimal). - Nt human readable. - Example: <id rt="550e8400-e29b-41d4-a "/> Other Identifiers may be reginally defined. E.g., ID extensin ICH = M8 Step 4 = CU =

23 ectd v4.0 Supprt Dcumentatin 4.2. Cntrlled Vcabularies 6. Cntrlled Vcabularies ectd v4.0 XML Message Basics Cntrlled Vcabularies Cntrlled Vcabularies (CV) enable interperability. Clear, unambiguus cmmunicatins between systems sending and receiving XML messages. Fr the XML elements that have cded values, a cntrlled vcabulary will be required t indicate the value f the cncept. Each cde has a cde system. The cde system may be managed by ICH, Regin r the Applicant. The specific assignment f cde system values can be fund in the detailed descriptin f OIDs and cntrlled vcabularies. Cntrlled vcabularies are defined external t the message. A cde is used as the identifier t cnvert the cde value int the meaningful terms that will be used in any system that implements the viewing f the infrmatin sent in the XML message. 5 types f Cntrlled Vcabularies Specified by ICH Specified Reginally Specified by HL7 Specified by External Organizatin Sender-defined CV Cntrlled vcabulary is prvided in the Cde List spreadsheet and genericde files (see zip file). 23

24 ectd v4.0 Supprt Dcumentatin ectd v4.0 XML Message Basics - Cdes v4.0 essential elements have cde and cde system attributes. Cde system indicates which cde list the cde references. Cde Cde gives the value f the cncept. Example: <cde cde="ich_2.5" cdesystem=" "/> 2 cde gives the value f the cncept Descriptin ich_2.3.s m2.3.s drug substance ich_2.3.p m2.3.p drug prduct ich_2.3.a.1 m2.3.a.1 facilities and equipment ich_2.3.a.2 m2.3.a.2 adventitius agents safety evaluatin ich_2.3.a.3 m2.3.a.3 excipients ich_2.3.r m2.3.r reginal infrmatin ich_2.4 m2.4 nnclinical verview ich_2.5 m2.5 clinical verview ich_2.6.1 m2.6.1 intrductin ICH CU ICH Dcument Type ICH Species Reginal CU x.x.x etc cdesystem identifies the cde list Cde lists

25 ectd v4.0 Supprt Dcumentatin ectd v4.0 XML Message Overview Message Header ectd v4.0 Message Message Header Cntrl Act Prcess Message Header cmes befre the paylad. <?xml versin="1.0" encding="utf-8"?> XML Declaratin Submissin Unit 1..1 Submissin 1..* Applicatin 1..* Message Header <submissinunit>. Paylad starts frm here. 25

26 ectd v4.0 Supprt Dcumentatin ectd v4.0 XML Message Overview - Paylad Unit f ne ectd sequence Display rder fr CU CTD heading Reference t Dcument Additinal infrmatin f CU Reference t CU being replaced ectd sequence number Cncept superir t Submissin Unit Cncept superir t Submissin Dcument Cntrl Act Prcess Submissin Unit Pririty Number 1..1 Cntext f Use 1..* DcumentRef 0..1 Keywrd 0..* Related Cntext f Use Sequence Number 1..1 Submissin Applicatin 1..* 1..* Dcument 0..* Keywrd Definitin * 0..* Reginally defined elements/ attributes Reginally defined elements/attributes Reginally defined elements/attr ibutes <cntrlactprcess> <subject> <submissinunit> <cmpnent> <priritynumber> <cntextofuse> <dcumentreferece> <replacementof> <relatedcntextofuse> <referencedby> <keywrd> <cmpnentof1> <sequencenumber> <submissin> <cmpnentof> <applicatin> <cmpnent> <dcument> Definitin f Senderspecified Keywrd <referencedby> <keywrddefinitin> 26

27 ectd v4.0 Supprt Dcumentatin ectd v4.0 XML Message Basics Submissin Unit, Submissin, Applicatin The submissin tracking infrmatin is specified by the Reginal/Mdule 1 Implementatin Guides. Rules and Cntrlled vcabulary is defined by Regins fr submissin unit, submissin and applicatin. One submissin unit per message is expected. 27

28 ectd v4.0 Supprt Dcumentatin Cntext f Use Related Cntext f Use (Cntext f Use Life Cycle) ectd v4.0 XML Message Basics - Cntext f Use What is "Cntext f Use"? It gives a cntext t the dcument it references. In ectd, the cntext is the CTD heading. Withut being referenced by a CU, a dcument is nt assigned t any CTD heading. Keywrd gives additinal infrmatin t the CU it is assigned (e.g., manufacturer). Cmbinatin f CU cde, cdesystem, and keywrd(s) define the cntext. - If any ne f them is different, the cntext is cnsidered different. CU status is "active" when it is relevant, "suspended" when it is remved, r "bslete" when it is replaced. Nte that "bslete" is nt used in the XML message because the system will change the status in its database when the CU is replaced (i.e., when relatedcntextofuse is present). Cntext f Use ID Rt = UUID Cde = Cde fr the CTD Heading Cde System = OID Status Cde = Active (r Suspended) DcumentReference.id = UUID Links dcument t the cntext f its use Keywrd.cde Additinal Infrmatin f this CU RelatedCntextOfUse.id = UUID Indicates cntent that is being replaced 28

29 ectd v4.0 Supprt Dcumentatin ectd v4.0 XML Message Basics Life Cycle Basics Life cycle peratin ccurs nly at Cntext f Use. - When a sender intends t replace/remve dcument previusly submitted, the technical peratin is t replace/remve the CU which references the intended dcument Cntext f Use Related Cntext f Use (Cntext f Use Life Cycle) Dcument desn't have status, and thus life cycle desn't ccur at dcument level. - Dcument is relevant t the review when referenced by active CU. - Dcument is nt relevant t the review when referenced by n active CU. CU is remved when it is submitted with statuscde "suspended". CU is replaced when new CU is submitted with Related Cntext f Use. Cntext f Use ID = UUID... UUID f the replacing CU Related Cntext f Use ID = UUID UUID f the CU being replaced 29

30 ectd v4.0 Supprt Dcumentatin Remving / Suspending Cntext f Use Elements Remving / Suspending Cntext f Use Elements (Life Cycle) If the CU needs t be remved at any time during the life cycle f the submissin, a submissin unit may indicate the remval f the CU by changing the statuscde element. Frm "active" t "suspended". Only the <priritynumber>, <id>, and <stauscde> elements are needed. Submissin f the ther infrmatin (e.g., dcument reference, keywrds) can be mitted. ID must be the same t identify the CU t be remved. priritynumber shuld be the same. Even if different value is prvided, it wn' be prcessed (i.e., the new priritynumber wuld nt be applied). Once suspended, the same CU (i.e., the same ID) cannt be reactivated. 30

31 ectd v4.0 Supprt Dcumentatin Replacing (Versining) Cntext f Use Elements Appraches t Changes in Cntext Grups Replacing (Versining) Cntext f Use Elements 2 reasns fr submitting a replacement: The submissin cntents (i.e., the dcument being referenced) have changed. The previus suspended submissin cntent needs t be resubmitted. CU Replacement can nly ccur between the same cmbinatin* f CU cde and keywrd cde. If any ne f them is different, CU replacement is nt allwed. Once being replaced; The status is autmatically changed t "bslete" by system, and the CU cannt be reactivated. The pririty number is released, s the replacing CU can have the same r different pririty number. Replacement can ccur between: One CU and ne CU One CU and many CUs Many CUs and ne CU Many CUs and many CUs *The cmbinatin includes bth the cde and cde system fr the Cntext f Use and Keywrd in rder t define the specific cntext grup under which the dcuments are gruped. 31

32 Changing Granularity ectd v4.0 Supprt Dcumentatin Replacing (Versining) Cntext f Use Elements (cnt'd) If yu want t change the cmbinatin by CU replacement, It is nt allwed. N means t add, remve, r change any f thse by CU replacement. Suspend the CU, and submit a new CU (i.e., new CU id) with edited infrmatin. - Reference the same dcument id if nt intending t change the dcument. What if the M4 Annex: Granularity Dcument is updated and there are changes t the allwed granularities? Still, changing the cmbinatin by CU replacement is nt allwed. Suspend the CU, and submit a new CU (i.e., new CU id) with edited infrmatin. 32

33 ectd v4.0 Supprt Dcumentatin Dcument Element Updates Keywrd Definitin display name change Updating infrmatin Besides CU life cycle, the ectd v4.0 has the functin that enables the sender t update the infrmatin previusly submitted. The infrmatin that can be updated are: Pririty Number Dcument title Dcument mediatype Dcument language keywrddefinitin displayname The update can affect beynd the sequence. Infrmatin t update Update affects Remarks Pririty Number Within the submissin This is t rerder the previusly submitted CUs. Dcument title Dcument mediatype Dcument language keywrddefinitin displayname Everywhere the dcument is referenced, even acrss the applicatin Everywhere within the same applicatin where the keywrddefinitin is referenced This is t crrect an errr (e.g., typ). If the cncept needs t be changed, a new dcument shuld be prvided. This is t crrect an errr (e.g., typ) r t update the display name withut changing the cncept. If the cncept needs t be changed, a new keywrddefinitin shuld be prvided. 33

34 10. COMPATIBILITY AND REFERENCE TO ectd V3.2.2 Transitin Mapping Message Internatinal Cuncil fr Harmnisatin f Technical Requirements fr Pharmaceuticals fr Human Use 34

35 ectd v4.0 Supprt Dcumentatin Transitin Mapping Message What is Transitin Mapping Message (TMM)? The message submitted frm the applicant t regulatr when the applicatin needs t transitin frm v3.2.2 t ectd v4.0 frmat during its life cycle. v3.2.2 Applicant Sequence 0000 v3.2.2 Regulatr Sequence 0001 Withut TMM, the applicant cannt transitin t v4.0 TMM V4.0 Mapping current v3.2.2 cntent t v4.0 Sequence 3 35

36 ectd v4.0 Supprt Dcumentatin Transitin Mapping Message (cnt'd) What shuld be transitined t v4.0 by submitting TMM? Only submissin cntent that has been submitted t the Regulatry Authrity shuld be included in the transitin mapping message Overview f Frward Cmpatibility All current submissin cntents shuld be transitined regardless f whether r nt the cntent will underg life cycle. - Excludes any leaf elements that were deleted r replaced. - Includes leaf elements that have append status and its assciated leaf. - N change t the CTD heading is allwed in transitin mapping message. Only tw files shuld be submitted fr the transitin mapping message - i.e., the submissinunit.xml and sha256.txt files. - File shuld nt be resubmitted. 36

37 ectd v4.0 Supprt Dcumentatin Transitin Mapping Message (cnt'd) Transitin Mapping Message Prcess 10.1 Overview f Frward Cmpatibility 37

38 ectd v4.0 Supprt Dcumentatin Transitin Mapping Message (cnt'd) The v4.0 schema is used fr the TMM. Instructins fr TMM are lcated in Sectin10 and 13. The entire applicatin s current view is transitined. Nt all v4.0 elements and attributes are used in the TMM. Different rules apply t sme elements and attributes. e.g., Submissin cde is set fr the TMM; n life cycle is allwed; n changes t current view are allwed. Only ne valid TMM will be allwed i.e., nce the cntent is transitined and the first v4.0 message is received, nly v4.0 messages will be prcessed fr that applicatin. 38

39 12. APPENDIX 2: VALIDATION OF THE ECTD V4.0 MESSAGE 13. APPENDIX 3: FORWARD COMPATIBILITY VALIDATION RULES ICH Validatin Rules Internatinal Cuncil fr Harmnisatin f Technical Requirements fr Pharmaceuticals fr Human Use 39

40 ectd v4.0 Supprt Dcumentatin ICH Validatin Rules The Appendix 2 and 3 f the Implementatin Guide gives the lists f ICH-harmnized validatin rules applied t the ectd v4.0 messages and TMM, respectively. If the message is invalid against the ICH Validatin Rules, it wuld be rejected in all the ICH regins. If the message is valid against the ICH Validatin Rules, there still are Reginal Validatin Rules that the message has t be cmpliant with. - If it is invalid against Reginal Validatin Rules, it culd be rejected in that regin. - Refer t Reginal Guidance fr reginal validatin rules. 40

41 ectd v4.0 Supprt Dcumentatin Specificatin fr Submissin Frmat This submissin frmat specificatin is additinal guidance regarding the submissin cntents and is separate frm the actual ectd v4.0 Implementatin Package Guidance is related t File frmat specificatin e.g., PDF paginatin, fnts, file size limits and security 41

42 12. APPENDIX 2: VALIDATION OF THE ECTD V4.0 MESSAGE 13. APPENDIX 3: FORWARD COMPATIBILITY VALIDATION RULES Questins, Change Requests Internatinal Cuncil fr Harmnisatin f Technical Requirements fr Pharmaceuticals fr Human Use 42

43 ectd v4.0 Supprt Dcumentatin Questin r Change Request? Submit an "ectd Q&A r Change Request" t the M8 member f yur party/regin. "ectd Q&A r Change Request" frm is fund at ectd v4.0 page n Thse nt residing in an ICH regin can frward it t the M8 Rapprteur r t the ICH Secretariat (admin@ich.rg) 43