New Drug Submission (NDS) in eCTD format

Greetings!

The guidance on marketing applications for drugs and biologics was finalized by the International Council on Harmonization (ICH) in 2003. Today the CTD format is recommended for marketing applications in several countries in the world and is mandatory in several regions including Canada, Japan, Europe and U.S.A.

The eCTD format has become mandatory in key markets for electronic submissions.

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Learn about New Drug Submission (NDS) for Chemical drugs, biologicals, biopharmaceuticals, biosimilars and chemical generics. Using the ICH Common Technical Document (CTD) module format outline, significant Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be analyzed and discussed and participants will work on a mock submission binder.

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