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EMA Publishes First EU eCTD v4.0 Validation Criteria and Updated Controlled Vocabularies
In 1st & 8th August 2025, the European Medicines Agency (EMA) announced two major milestones in the transition to electronic Common...

Sharan Murugan
Aug 102 min read
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Health Canada: Validation Rules for Regulatory Transactions in eCTD and Non-eCTD Formats
Health Canada has released detailed guidances addressing the validation rules for regulatory transactions submitted in two formats: "...

Sharan Murugan
Jan 263 min read
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South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template
The South African Health Products Regulatory Authority (SAHPRA) has provided updated guidance for " ECTD Validation And Technical...

Sharan Murugan
Sep 9, 20242 min read
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Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format
Health Canada recently published an updated guidance on "Validation rules for regulatory transactions provided to Health Canada in the...

Sharan Murugan
Nov 30, 20231 min read
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South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS
Recently (05 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released the template "Validation Template For...

Sharan Murugan
May 9, 20231 min read
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EMA Checklist: Updated Validation checklist for Type II quality variations
Recently on 10th February 2023, the European Medicines Agency (EMA) updated and released their "Validation checklist for Type II quality...

Sharan Murugan
Feb 14, 20231 min read
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ICH's updated Draft Guidelines on Analytical Method Development
Two draft guidelines were issued by the International Council for Harmonization (ICH) on 31 March 2022 (Thursday), intended to support...

Sharan Murugan
Apr 4, 20221 min read
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