marketing authorization application
- Guideline or reference source
- EUTCTG European Union Telematics Controlled Terms Glossary of terms
- Definition
- Across all European markets, plus Australia, New Zealand, South Africa, and Israel (exceptions amongst major markets include USA, Canada, China and Japan), the Marketing Authorisation Application (MAA) is a common document used as the basis for a marketing application (an application for approval to market the product based on a full review of all quality, safety, and efficacy data, including clinical study reports). In the USA, the New Drug Application (NDA) is the MAA equivalent. In Canada, the New Drug Submission (NDS) is the MAA equivalent. An MAA is comprised of 4 parts: Part 1: Summary of the Dossier includes application forms, summary of Product Characteristics, packaging, Expert Reports. Part 2: Chemical, Pharmaceutical, and Biological Documentation: drug substance and drug product. Part 3: Pharmacological and Toxicological (Preclinical) Documentation is a report of all animal pharmacology, toxicology, and pharmacokinetics studies. Part 4: Clinical Documentation is a report of all Phase I, II, III, IV, V clinical studies conducted up to the time of submission.
- Abbreviation for
- MAA
- Narrower Term
- exceptional circumstances
- Related Term
- application type
- duplicate
- marketing authorization
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