Module 1 2021

25/06/2021

Why adopt the CTD/eCTD?

• These are the standards used most widely ─ ICH regions and more broadly

• The standards are a “higher/highest common denominator” so the lower standards can usually be easily created from the documents and submissions ─ For example, the NeeS is a simplified eCTD, so if you can create an eCTD you can create a NeeS ─ Even creating some of the other standards are easier if you start with the CTD/eCTD (e.g. the ASEAN CTD)

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Standards where there are none (published)

• Having made the investment, use the document and submission standards whenever you can • The standards for an electronic document make sense whether there is a Marketing Application immediately planned or not ─ Bad electronic documents are more difficult to use than bad paper! ─ And it is extra effort to upgrade the documents later • Extrapolate from the eCTD and NeeS standards when you are creating other submission types where there might not be a published standard ─ CTAs in Europe and the rest of the world ─ Submissions for Scientific Advice, Paediatrics or Orphan Drug Designation

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