It is a set of documents which contains technical information about the drug product. The information includes administrative, quality, non-clinical & clinical information.
Dossier Submission Formats
- CTD – Common Technical Documents
- eCTD – Electronic Common Technical Documents
- ACTD – ASEAN (Association of South East Asian Nation) Common Technical Documents
- Country specific format
Common Technical Document (CTD)
A standardized format for regulatory submissions, divided into five modules:
- Module 1: Regional administrative & prescribing information
- Module 2: Overview & summary of modules 3–5
- Module 3: Quality (chemistry, manufacturing, and controls – CMC)
- Module 4: Non-clinical study reports
- Module 5: Clinical study reports
New Drug Application (NDA)
Submitted to regulatory agencies (like the FDA) for approval of a new drug in the market.
Abbreviated New Drug Application (ANDA)
Used for generic drug approvals, proving bioequivalence to an already approved product.
Investigational New Drug (IND) Dossier
Required for clinical trial approval before testing a new drug in humans.
Drug Master File (DMF)
Confidential document submitted to regulatory authorities that provides detailed information about active pharmaceutical ingredients (API) or excipients.
Biologics License Application (BLA)
Submitted for biologic products like vaccines and monoclonal antibodies.
Marketing Authorization Application (MAA)
Required for drug approval in the European Union (EU) and other regions.
Regulatory Agencies Handling Dossiers
- US: Food and Drug Administration (FDA)
- EU: European Medicines Agency (EMA)
- India: Central Drugs Standard Control Organization (CDSCO)
- Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
- China: National Medical Products Administration (NMPA)
Related Topics: