eCTD Guidance Document - eSubmission - Europa

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4. ADVICE ON SPECIFIC APPLICATION TYPES 4.1 Initial MA Applications The recommended start for an eCTD life cycle is the initial MA application. It should normally be provided as sequence 0000. Any other number should be justified in the cover letter. All documents included should have the operation attribute “New” and be placed in the relevant sections in line with the different eCTD specifications. The submission type should be initial-maa. The procedure type depends on the application that is made. Please find below an overview of the different application types: Procedure Procedure type Centralised Procedure (CP) centralised Decentralised Procedure (DCP) decentralised Mutual Recognition Procedure (MRP) mutual-recognition National national Repeat Use Procedure (RUP) mutual-recognition For responses to questions documents, see section 3.2.6. The following milestones of the procedures are proposed as appropriate sequences to be submitted during the assessment of an initial new application. Although the example relates to the centralised procedure similar principles can be applied to other procedures. Day Number eCTD milestone sequence Notes -14 Initial submission -1 Response to business validation issues if required 121 Response to List of Questions (LoQ) 181 Response to List of Outstanding Issues (LoOI) 210 Final English Application as agreed at opinion 215 Provision of translations 245 Provision of final agreed translations following linguistic review It is not also required to send interim working versions of the product information before this point as eCTD 270 Decision I.e. final amended documentation if any changes occur during the Standing Committee phase 4.2 Variation Applications All types of variations should be submitted within the eCTD as new sequences. The cover letter and application form should be included in the eCTD but the majority of NCAs also require these items to be submitted in signed paper format. Please refer to the Notice to Applicants, Volume 2A, Chapter 7 for details. In the eCTD, the documents should be included as electronic sourced document and not as a scanned copy of the signed documents. Documents related to the variation should be included in relevant sections or be deleted by use of the appropriate document operation attribute. Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD Applications Version: 1.0 May 2009 Page 18 of 41
The submission type for the sequence has to be for: Variation type Submission type Type IA variation var-type1a Type IB variation var-type1b Type II variation var-type2 The procedure type should be for variation of the procedure: Procedure Procedure type Centralised Procedure (CP) centralised Mutual Recognition Procedure (MRP) mutual-recognition National national However, in relation to the first variation in eCTD format, the applicant is strongly encouraged to also submit a so called “baseline eCTD”, i.e. to submit the current dossier in an eCTD format, at least Module 1, the cover letter and product information as a minimum, and Module 3. This ”baseline eCTD” would then be submitted as sequence 0000 and the first variation in eCTD format submitted as sequence 0001. It should be clearly stated in the cover letter of the “baseline eCTD” that the content of the current dossier has not been changed but only the dossier format. Parallel variations should be submitted as individual sequences. Problems can occur in cases where a variation is not approved whilst a subsequent variation is approved. In such case a new sequence could be submitted containing the old section by replacing or deleting the submitted sections reaffirming the registered status of the modules. The following milestones of the procedures are proposed as appropriate sequences to be submitted during the assessment of variations. Although the example relates to the centralised procedure it could be applied to other procedures: Type IA & IB Variations Day Number eCTD milestone sequence Notes 1 Start of the procedure e.g. “Start of the procedure phone number changes” Type II Variations Day Number eCTD milestone sequence Notes 1 Start of the procedure e.g. “Start of the procedure indication enlargement” 91 Response to RSI If applicable 91 Final English +5 Provision of translations +30 Provision of final agreed translations following linguistic review It is also not required to send interim working versions of the product information before this point as eCTD Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD Applications Version: 1.0 May 2009 Page 19 of 41
Page 1 and 2: DRAFT FOR TESTING Guidance for Indu
Page 3 and 4: Table of Contents 1. INTRODUCTION .
Page 5 and 6: A brief glossary of terms (for the
Page 7 and 8: Please check for specific NCA guida
Page 9 and 10: 2.9.3 Sequence Numbers Sequence num
Page 11 and 12: EMEA, a similar internal virus chec
Page 13 and 14: 3. MODULE SPECIFIC INFORMATION 3.1
Page 15 and 16: elated documents are aligned with t
Page 17: Listing of Clinical Studies should
Page 21 and 22: 4.5 PSURs The submission of a Perio
Page 23 and 24: The application of a medicinal prod
Page 25 and 26: Annex 2 Guidance on Text Searchable
Page 27 and 28: Annex 3 Guidance and Best Practice
Page 29 and 30: Table 1 - Advantages and disadvanta
Page 31 and 32: 3.2 Drug Substance (32s) Attributes
Page 33 and 34: 3.2.2.2 Approach 2 - New XML sectio
Page 35 and 36: 3.3 Drug Product (32p) - Product/Do
Page 37 and 38: 3.3.3.2 Approach 2 - Separate XML s
Page 39 and 40: 3.3.3.3 Approach 3 - Different XML
Page 41: 3.3.4 Manufacturer of drug product

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