Regulatory Blog

This guidance , " Guidance on Controlled Substances Company Meetings " , issued by Swissmedic and valid from 06 March 2026, outlines the framework for Controlled Substances Company Meetings. These meetings are designed to support companies handling controlled substances or involved in the cultivation of cannabis for medical purposes, enabling efficient interaction with Swissmedic’s Narcotics Division. Background Companies dealing with controlled substances must comply with st

This guidance , published in March 2026 by the European Directorate for the Quality of Medicines & HealthCare (EDQM) , introduces new approaches for accelerating the assessment of Certificates of Suitability (CEP) applications. It focuses on two key pathways: Fast-track assessment Reliance-based assessment Both approaches aim to improve regulatory efficiency, reduce delays, and ensure timely access to medicines. CEP procedures are essential for demonstrating that a substance

Introduction This guidance, "General Considerations for the Use of New Approach Methodologies in Drug Development" , published as a draft in March 2026 , provides a framework for using New Approach Methodologies (NAMs)  in drug development. NAMs include approaches such as: In vitro models (simple and complex systems) In chemico methods In silico modelling The goal of this guidance is to improve human-relevant toxicology prediction  and reduce reliance on animal testing. Backg