CTD modules 2, 3, 4 and 5 for registered complementary medicine applications
Guidance on dossier information required for registered complementary medicine applications, to be consistent with the Common Technical Document (CTD) format.
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Purpose
Guidance for applicants on information required for modules 2- 5 in dossiers for applications for registered complementary medicines to be consistent with the Common Technical Document (CTD) format.
The CTD modules 2 to 5 registered complementary medicines data requirements matrix at the end of the document provides a useful summary of the CTD module documents required for new registered complementary medicine applications.
Guidance
This Guidance is presented as downloadable files because of its length.
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Page history
Title changed from 'CTD modules 2, 3, 4 and 5 for registered complementary medicine applications- Guidance for applicants' to 'CTD modules 2, 3, 4 and 5 for registered complementary medicine applications ' as part of migration to new 'Guidance' content type:
- Consistent ‘Purpose’ heading.
- ‘Page history’ section replaces document version history.
Original publication.
Information for original publication extracted from pages 156 to 201 of ARGCM V8.0.
Changes include:
- new introductory paragraph
- data matrix moved to back of document
- information under clinical pharmacokinetics and pharmacodynamics revised and corrected
- headings changed in matrix to be consistent with ICH M4Q, M4S and M4E documents
- table numbers changed in matrix
- requirements for 3.2.S.2 corrected for RCM 5 from ‘O’ to ‘D’
- requirements for 3.2.P.5.1, 3.2.P.5.4 and 3.2.P.7 corrected to ‘D’ for RCM 2 to align with the Mandatory requirements for an effective registered medicines application.
- Guidance related to generic medicines and medicines only containing ingredients permitted for listed medicines has been moved to the relevant modules.
Title changed from 'CTD modules 2, 3, 4 and 5 for registered complementary medicine applications- Guidance for applicants' to 'CTD modules 2, 3, 4 and 5 for registered complementary medicine applications ' as part of migration to new 'Guidance' content type:
- Consistent ‘Purpose’ heading.
- ‘Page history’ section replaces document version history.
Original publication.
Information for original publication extracted from pages 156 to 201 of ARGCM V8.0.
Changes include:
- new introductory paragraph
- data matrix moved to back of document
- information under clinical pharmacokinetics and pharmacodynamics revised and corrected
- headings changed in matrix to be consistent with ICH M4Q, M4S and M4E documents
- table numbers changed in matrix
- requirements for 3.2.S.2 corrected for RCM 5 from ‘O’ to ‘D’
- requirements for 3.2.P.5.1, 3.2.P.5.4 and 3.2.P.7 corrected to ‘D’ for RCM 2 to align with the Mandatory requirements for an effective registered medicines application.
- Guidance related to generic medicines and medicines only containing ingredients permitted for listed medicines has been moved to the relevant modules.