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UK MHRA Guidance: Modifying Clinical Trial Approvals in the UK
With the 2025 amendments to the Medicines for Human Use (Clinical Trials) Regulations taking effect on 28 April 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided comprehensive guidance “ Clinical trials for medicines: modifying a clinical trial approval” for sponsors and investigators which outlines how to manage changes to an approved clinical trial of a medicinal product. Types of Modification Modifications to a clinical trial approval f
Sharan Murugan
Nov 53 min read
Philippines FDA Draft Guidelines: Navigating Post-Approval Changes, Device Variations, and Establishment Inspections in 2025
The Philippines FDA ("FDA Philippines") continues to enhance its regulatory frameworks to streamline processes and align with international best practices. Three recent draft guidelines open for public comments address critical areas impacting pharmaceutical products and medical devices for comment: Implementing Guidelines on the Post-Approval Changes of Registered Pharmaceutical Products for Human Use (for human medicines) Guidelines on the Application for Variation of the
Sharan Murugan
Nov 12 min read
South Africa SAHPRA’s Guidelines: for Labelling of Medicines Intended for Human Use and Adverse Drug Reactions (ADRs) Reporting
The South African Health Products Regulatory Authority (SAHPRA) plays a pivotal role in safeguarding public health by ensuring medicines are safe, effective, and properly labelled, and by maintaining robust pharmacovigilance through adverse drug reaction (ADR) reporting. In its continuous mission to strengthen medicine safety and promote patient wellbeing, the SAHPRA has issued two crucial documents: The Guideline for Labelling of Medicines Intended for Human Use , and The Gu
Sharan Murugan
Nov 12 min read