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May 142 min read

Health Canada: Guidance on Preparation of Regulatory Activities in Non-eCTD Format & Filing submissions electronically

Health Canada recently (13 May 2024) updated its guidance "Preparation of Regulatory Activities in Non-eCTD Format" (electronic Common...

Apr 2, 20231 min read

Japan's PMDA: Reporting ADR & Defects during Clinical Trials using e-Application Data System

Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued guidance “System...

Aug 2, 20221 min read

USFDA Guidance: Electronic Submission of Expedited Safety Reports From IND- Exempt BA/BE Studies

Today (August 2, 2022) FDA published draft guidance for the industry, “Electronic Submission of Expedited Safety Reports from IND-Exempt...

Sep 5, 20211 min read

Updated Guidance for e-Submissions for CEP applications

As the eCTD format is mandatory for the submission of all applications for Certificates of Suitability to the monographs of the European...