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eCTD Guidance Document - Europa
esubmission.ema.europa.euGuidance for Industry on Providing Regulatory Information in Electronic Format: eCTD Version: 2.0, August 2011 3 (46) 1. INTRODUCTION . This guidance document is intended to assist pharmaceutical companies with the submission of regulatory
eCTD Guidance Document - Europa
esubmission.ema.europa.euThis guidance document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic Common Technical Document format (eCTD) to the National Competent Authorities