Search


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
1 day ago2 min read
Â
Â


European Commission Insights: Study on the Deployment of Artificial Intelligence in Healthcare – 2025
On 8 August 2025,  the European Commission  released an in-depth study on the " Deployment of artificial intelligence (AI)  in healthcare...

Sharan Murugan
1 day ago2 min read
Â
Â


EMA Procedural Advice: Paediatric Applications – A Comprehensive Guide for Applicants
On 8 August 2025 , the European Medicines Agency (EMA)Â published the latest revision (Rev. 14) of its "Procedural Advice on Paediatric...

Sharan Murugan
1 day ago2 min read
Â
Â


EMA’s Feedback: On Replacing Titanium Dioxide (TiO₂) in Medicinal Products: Critical Challenges, Limited Alternatives (Human & Veterneary)
The European Medicines Agency (EMA) Â submitted its updated report to the European Commission (EC) Â evaluating the feasibility of...

Sharan Murugan
5 days ago3 min read
Â
Â


UK MHRA Med Dev Guidance: Clinical Investigations for Medical Devices - What Sponsors Need to Know in 2025
Medical devices, whether diagnostic, therapeutic, or assistive, undergo rigorous scrutiny before entering the UK market. One of the most...

Sharan Murugan
5 days ago3 min read
Â
Â


UK MHRA Guidance: Adverse Event Reporting in Digital Mental Health Technologies (DMHTs)
The proliferation of Digital Mental Health Technologies (DMHTs) —ranging from self-help apps and online therapy services to artificial...

Sharan Murugan
Aug 22 min read
Â
Â