Regulatory Blog

The UK regulatory landscape for clinical trials is undergoing a significant transformation with the implementation of updated Medicines for Human Use (Clinical Trials) Regulations, effective from 28 April 2026. These changes emphasize quality by design, risk-based approaches, and strengthened manufacturing standards, ensuring both participant safety and data integrity. Guidance: Clinical trials for medicines: Guidance on Quality and Risk Proportionality Scope This guidance ap

India’s Central Drugs Standard Control Organization (CDSCO) has released a draft notification dated 09 March 2026  proposing amendments to the Drugs Rules, 1945 to establish a structured framework for managing post-approval manufacturing changes. This draft notification introduces clear regulatory requirements for notifying authorities when manufacturers make changes to manufacturing processes, excipients, packaging, shelf life, specifications, testing procedures, or docume

Introduction The Therapeutic Goods Administration (TGA) released multiple New & updated guidance s on 16 March 2026 , that provides clarity on when certain software products may be excluded from medical device regulatory requirements . With the rapid growth of digital health technologies, this guidance helps distinguish between software that requires regulation and software that can be safely excluded based on its intended use and risk profile. Background As digital health s