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May 172 min read

EMA Guidance: EudraVigilance Registration Documents

The European Medicines Agency (EMA) on Thursday (16 May, 2024) released an updated guidance on "EudraVigilance Registration Documents"...

Jun 6, 20231 min read

South Africa's (SAPHRA): Guideline on Pharmacovigilance Systems

Earlier today (06 June, 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline on...

May 13, 20232 min read

UK MHRA: Guidance on Qualified Person responsible for QPPV & PSMF

Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated "Guidance on the qualified...

Dec 5, 20212 min read

Guidance on QPPV including Pharmacovigilance System Master Files– MHRA

UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on requesting a pharmacovigilance system master file...