Regulatory Blog

Artificial Intelligence (AI) and Machine Learning (ML) are transforming healthcare globally, offering powerful tools for diagnosis,...

Artificial Intelligence and Machine Learning (AI/ML) are increasingly used in medical devices—from diagnostic imaging software to digital...

On 8 August 2025,  the European Commission  released an in-depth study on the " Deployment of artificial intelligence (AI)  in healthcare...

On 18 July 2025, the European Commission published detailed Guidelines on the scope of the obligations for providers of general-purpose...

In a world where artificial intelligence (AI) is moving rapidly from theory to practice, regulators are tasked with keeping pace—not only...

In an era where data drives decisions and innovation defines progress, the European Medicines Agency (EMA) and Heads of Medicines...

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has launched Phase 2 of its AI Airlock programme , supported by a...

What if the agonizing wait for drug approvals could be slashed from days to minutes? Imagine a future where breakthrough therapies reach...

In the evolving landscape of medicines regulation, data and artificial intelligence (AI) have become pivotal tools to enhance public and...

The world of pharma and life sciences is abuzz with a major announcement: Veeva Systems has just unveiled Veeva AI , a groundbreaking...

The European Medicines Agency (EMA) has unveiled a comprehensive Artificial Intelligence (AI) Work Plan  to guide the integration of AI...

The U.S. Food and Drug Administration (FDA) has issued a draft guidance document titled “ Artificial Intelligence-Enabled Device Software...

The U.S. Food and Drug Administration (FDA) released a draft guidance earlier today (07 January, 2025) outlining " Considerations for...

The US Food and Drug Administration (USFDA)  has issued its final guidance on " Marketing Submission Recommendations for a Predetermined...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has launched (4th December 2024) a groundbreaking pilot scheme "...

The advancement of Artificial Intelligence (AI)  is transforming many industries, and the pharmaceutical and regulatory sectors are no...

The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...

The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced (09 May, 2024) the “AI Airlock - The Regulatory Sandbox...

Last Friday (03 May 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Software and...