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Today (August 2, 2022) FDA published draft guidance for the industry, “Electronic Submission of Expedited Safety Reports from IND-Exempt...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