Regulatory Blog

The South African Health Products Regulatory Authority (SAHPRA) has issued an updated "Guideline for Destruction of Medicines and Scheduled Substances" outlining the safe and compliant destruction of medicines and scheduled substances across the country. This update aligns regulatory expectations with the Medicines and Related Substances Act (Act 101 of 1965)  and the National Environmental Management: Waste Act (2008) , reinforcing SAHPRA’s commitment to protecting public

The U.S. Food and Drug Administration (FDA) has released its updated guidance “ How to Prepare a Pre-Request for Designation (Pre-RFD) ” , issued on November 6, 2025 . This guidance provides companies with a clear roadmap for obtaining early, non-binding feedback on the regulatory classification of their products — especially combination products , which often sit at the intersection of drugs, devices and biologics. The updated guidance strengthens transparency, clarifies ex

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