3. Format of the Submission – the Common Technical Document (CTD)

Although it is recognised that the non-clinical data help to address the safety of the product, there are non-clinical studies (primary, secondary pharmacology stating the effects of the active substance on the different organs showing or not showing the intended efficacy. Therefore, the key issue here is to know that this module contains the result of the investigations performed in vitro and in animals (non-clinical data).

Module 4

• presents the non-clinical reports (pharmacology/toxicology) - non-clinical study reports).
• structure and content are specified in the ICH M4S guidelines.
• main headings:
  • 4.1 Table of contents of Module 4
    • 4.2 Study reports

- 4.2.1 Pharmacology

- 4.2.2 Pharmacokinetics

- 4.2.3 Toxicology

• • 4.2 Literature references used in Module 4.