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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...
Sharan Murugan
May 14, 20242 min read
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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...
Sharan Murugan
Apr 2, 20231 min read
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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Today (August 2, 2022) FDA published draft guidance for the industry, “Electronic Submission of Expedited Safety Reports from IND-Exempt...
Sharan Murugan
Aug 2, 20221 min read
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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...
Sharan Murugan
Sep 5, 20211 min read
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