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South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1
Recently (18 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Application form template...

Sharan Murugan
May 21, 20231 min read
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Swissmedic: eCTD v4.0 Implementation Guide published
Earlier today (17 March 2023) Switzerland's SwissMedic released published the "Implementation Guide for eCTD v4.0" and the implementation...

Sharan Murugan
Mar 17, 20231 min read
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EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations
Recently EMA released an updated guidance document for the purpose of simplifying the completion of the application form process for...

Sharan Murugan
Oct 13, 20221 min read
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USFDA Guide: Updated eCTD 4.0 - TECHNICAL CONFORMANCE GUIDE,
Recently USFDA released an updated "Electronic Common Technical Document (eCTD) Technical Conformance Guide" that revised some sections...

Sharan Murugan
Sep 17, 20221 min read
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