Regulatory Blog

Artificial Intelligence (AI) is no longer a future concept in pharmaceutical research—it is already influencing how drugs and biological products are discovered, developed, manufactured, and monitored throughout their lifecycle. However, when AI outputs are used to support regulatory decisions , questions of trust, transparency, and accountability become critical. Recognising this, global regulators have begun defining expectations for the responsible use of AI in drug devel

Staying compliant in the life sciences industry has never been more complex. Regulatory changes move faster than ever, global markets evolve continuously, and expectations from agencies keep rising. In this environment, regulatory intelligence is no longer a luxury. It is a core operational pillar. For my 1000th post on Regulatory Affairs News, I’m sharing a full breakdown of the latest regulatory intelligence sources, tools, databases, and best practices . I’m also attachin

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...

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