Regulatory Submission
A formal application package submitted to a regulatory authority (FDA, EMA, Health Canada, etc.) seeking approval to market a drug. Submissions include all preclinical and clinical data, manufacturing information, labelling, and risk management plans. The format follows regional (CTD) or international (eCTD) standards.
Technical Context
Major submission types: IND (investigational new drug — enables clinical trials), NDA (new drug application — seeks marketing approval for new drugs), BLA (biologics license application — for biological products), sNDA/sBLA (supplemental — new indications, formulations, or safety updates), and ANDA (abbreviated — for generic drugs). The Common Technical Document (CTD) format standardises submissions globally: Module 1 (regional administrative), Module 2 (overviews/summaries), Module 3 (quality/CMC), Module 4 (nonclinical), Module 5 (clinical). Electronic submission (eCTD) is mandatory in the US, EU, and Japan. Timeline: FDA standard review 10 months (PDUFA date), priority review 6 months; EMA centralised procedure approximately 210 days active review plus clock stops. Pre-submission meetings (pre-IND, end-of-Phase-II, pre-NDA) align expectations between sponsor and regulator.