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Sep 92 min read

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...

Nov 30, 20231 min read

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...

May 9, 20231 min read

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...

Feb 14, 20231 min read

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...

Apr 4, 20221 min read

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...