Update of ectd Module 1 specification for South Africa V2.0

Transcription

1 Update of ectd Module 1 specification for South Africa V2.0 Dr. Silke Nolkemper, Senior Business Consultant Christine Hirt, Managing Consultant Pretoria Copyright 2016 EXTEDO. All rights reserved.

2 2 New Documents South African Specification for ectd Regional - Module1 v2.0 Validation Criteria for the South African Module 1 v2.0 Guidance for the Submission of Regulatory Information in ectd Format - v2.0 ectd Checksums - v2.0 ectd Implementation Guide v1.0 ectd Q&A v3.0 (will be published after the event to include possible discussions from the industry meeting)

3 3 New Documents where to find it

4 4 Changes in the envelope Submission type now repeatable, i.e. more than one submission type can be added to the envelope Changes submission types: na-cams: Complementary and Alternative Medicines pre-reg-cams: Complementary and Alternative Medicines post-reg-cams: Complementary and Alternative Medicines Deleted submission types: pre-reg-pa-insp: Pharmaceutical & Analytical and Inspectorate post-reg-pa-insp: Pharmaceutical & Analytical and Inspectorate New submission types for responses to post registrations baseline submission

5 5 New submission types in detail Response to post-registration recommendation: resp-post-reg-insp: Inspectorate resp-post-reg-pa: Pharmaceutical and Analytical resp-post-reg-cl: Clinical resp-post-reg-pn: Proprietary name change application resp-post-reg-pn-update: Updates following a proprietary name change approval resp-post-reg-hcr: Applicant transfer, name and address change of applicant resp-post-reg-biol: Biologicals and biosimilars resp-post-reg-cm: Complementary Medicines Baseline submissions baseline: Reformatting from Paper to ectd

6 6 Envelope Attributes

7 7 Specific Module 1 documents The operation attribute should always be New for the following leaf elements provided with all ectd-sequences: 1.0 letter of application application form proof of payment electronic copy declaration tabulated schedule of amendments For the application form leaf elements the operation attribute may be replace only if it had to be corrected. Note that if a tracking table is submitted as a separate document, it has no lifecycle and should therefore always be submitted with the document operation attribute new.

8 8 Related Sequence

9 9 Structure of 3.2.R Specific file and folder structure mandatory for section 3.2.R File and folder names controlled by new validation criteria

10 10 New Validation Criteria (1) Lifecycle of specific documents in M1, e.g. Checking hyperlinks in M1

11 11 New Validation Criteria (2) Checking 3.2.R structure Checking related sequence

12 12 New Validation Criteria (3) More rules about pdf settings

13 13 New Validation Criteria (4) Check of cross sectional lifecycle

14 14 Lifecycle Operations - Overview Operation can only be correctly applied within the same context Same element in DTD Same element attribute associated with the leaf Same substance and manufacturer for M 3.2.S Same granularity(!)

15 18 Baseline submission The baseline submission should reflect the status most recently approved. There is no content validation and no evaluation process involved. The envelope element application type for a baseline submission should be baseline. A baseline always has to be submitted as a separate sequence. Timing of the submission: Preferred option: At the beginning of the transition from paper to electronic as sequence 0000, but also accepted later in the lifecycle For products with amendments planned for Module 3 Before or with an amendment (of e.g. Module 3) BUT as a separate sequence. To reflect the status most recently approved, all the documents of Module 1 relevant to the registration need to be included into the baseline submission.

16 for further information phone: Copyright 2016 EXTEDO. All rights reserved.