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  VIETNAM | Ministry of Health Updates Drug Registration Framework — Post-Authorisation Evidence Requirements Continue

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  VIETNAM | Ministry of Health Updates Drug Registration Framework — Post-Authorisation Evidence Requirements Continue

  2026, August 2026, Members-Only, Minor Update, Vietnam
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VIETNAM | Ministry of Health Updates Drug Registration Framework — Post-Authorisation Evidence Requirements Continue

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VIETNAM | Ministry of Health Updates Drug Registration Framework — Post-Authorisation Evidence Requirements Continuestuart.mccully2026-09-12T17:14:16+00:00

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  UK | MHRA Advises Against Infant Use of Rectal Catheters — Lack of Clinical Evidence Drives Device Safety Action

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  UK | MHRA Advises Against Infant Use of Rectal Catheters — Lack of Clinical Evidence Drives Device Safety Action

  2026, August 2026, Medical Devices, Members-Only, Minor Update, UK
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UK | MHRA Advises Against Infant Use of Rectal Catheters — Lack of Clinical Evidence Drives Device Safety Action

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UK | MHRA Advises Against Infant Use of Rectal Catheters — Lack of Clinical Evidence Drives Device Safety Actionstuart.mccully2026-09-12T17:05:12+00:00

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  UK | MHRA Reaffirms Childhood Vaccine Safety — Real-World Data Underpins Continuous Surveillance

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  UK | MHRA Reaffirms Childhood Vaccine Safety — Real-World Data Underpins Continuous Surveillance

  2026, August 2026, Members-Only, Minor Update, UK
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UK | MHRA Reaffirms Childhood Vaccine Safety — Real-World Data Underpins Continuous Surveillance

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UK | MHRA Reaffirms Childhood Vaccine Safety — Real-World Data Underpins Continuous Surveillancestuart.mccully2026-09-12T17:02:14+00:00

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  UK | HRA Backs Rare Disease Pathway — But Says Real-World Evidence Needs Clear Governance

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  UK | HRA Backs Rare Disease Pathway — But Says Real-World Evidence Needs Clear Governance

  2026, August 2026, Members-Only, Minor Update, Rare Diseases, UK
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UK | HRA Backs Rare Disease Pathway — But Says Real-World Evidence Needs Clear Governance

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UK | HRA Backs Rare Disease Pathway — But Says Real-World Evidence Needs Clear Governancestuart.mccully2026-09-12T16:58:04+00:00

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  EU | EMA and HMA Consult on Data Standards Framework — Formalising How the Regulatory Network Manages Data Standards

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  EU | EMA and HMA Consult on Data Standards Framework — Formalising How the Regulatory Network Manages Data Standards

  2026, August 2026, EMA, EU, Members-Only, Minor Update
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EU | EMA and HMA Consult on Data Standards Framework — Formalising How the Regulatory Network Manages Data Standards

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EU | EMA and HMA Consult on Data Standards Framework — Formalising How the Regulatory Network Manages Data Standardsstuart.mccully2026-09-12T15:47:45+00:00

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  EU | Article 50 AI Transparency Requirements Now Apply — Human Review Exception Important for RWR Publications

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  EU | Article 50 AI Transparency Requirements Now Apply — Human Review Exception Important for RWR Publications

  2026, AI, August 2026, EU, Members-Only, Minor Update
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EU | Article 50 AI Transparency Requirements Now Apply — Human Review Exception Important for RWR Publications

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EU | Article 50 AI Transparency Requirements Now Apply — Human Review Exception Important for RWR Publicationsstuart.mccully2026-09-12T15:27:59+00:00

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  EU | Digital Omnibus Resets High-Risk AI Timelines and Expands Rules for Bias and Real-World Testing

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  EU | Digital Omnibus Resets High-Risk AI Timelines and Expands Rules for Bias and Real-World Testing

  2026, AI, August 2026, EU, Members-Only, Minor Update
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EU | Digital Omnibus Resets High-Risk AI Timelines and Expands Rules for Bias and Real-World Testing

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EU | Digital Omnibus Resets High-Risk AI Timelines and Expands Rules for Bias and Real-World Testingstuart.mccully2026-09-12T15:23:35+00:00

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  BRAZIL | INAEP Finalises Its Decision-Making Body — Ethics-System Reform Moves From Transition to Implementation

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  BRAZIL | INAEP Finalises Its Decision-Making Body — Ethics-System Reform Moves From Transition to Implementation

  2026, August 2026, Brazil, Members-Only, Minor Update
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BRAZIL | INAEP Finalises Its Decision-Making Body — Ethics-System Reform Moves From Transition to Implementation

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BRAZIL | INAEP Finalises Its Decision-Making Body — Ethics-System Reform Moves From Transition to Implementationstuart.mccully2026-09-12T14:57:32+00:00

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  USA | FDA Explores GenAI Medical Device Framework — RWD Could Shape Premarket and Postmarket Evidence

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  USA | FDA Explores GenAI Medical Device Framework — RWD Could Shape Premarket and Postmarket Evidence

  2026, AI, August 2026, Members-Only, Moderate Update, USA
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USA | FDA Explores GenAI Medical Device Framework — RWD Could Shape Premarket and Postmarket Evidence

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USA | FDA Explores GenAI Medical Device Framework — RWD Could Shape Premarket and Postmarket Evidencestuart.mccully2026-09-12T14:52:08+00:00

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  GREECE | Legacy NIS Circulars Face 1 October Publication Test

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  GREECE | Legacy NIS Circulars Face 1 October Publication Test

  2026, August 2026, Greece, Members-Only, Moderate Update
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GREECE | Legacy NIS Circulars Face 1 October Publication Test

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GREECE | Legacy NIS Circulars Face 1 October Publication Teststuart.mccully2026-09-12T14:47:36+00:00