CTD (Common Technical Document)

The internationally standardised dossier format used to register a pharmaceutical product with a regulator.

Definition

The Common Technical Document is an internationally harmonised format for the regulatory dossier submitted to register a pharmaceutical product. Tier 1 markets require a full CTD; many Tier 3 markets accept a lighter 'CTD-lite' version alongside a COPP and free-sale certificate.

Why It Matters

Dossier complexity is one of the biggest drivers of registration cost and timeline difference between market tiers.