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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

Show all page updates (2)

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.