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EMA Guidance: Procedural Advice on Paediatric Applications
The European Medicines Agency (EMA) has issued updated guidance " Procedural advice on Paediatric Applications " to support stakeholders...
Sharan Murugan
Apr 18, 20253 min read
UK MHRA Guidance: Risk Minimisation Measures for Medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on " Risk Minimisation Measures (RMMs) for...
Sharan Murugan
Apr 18, 20252 min read
EMA Draft Guideline: Quality Aspects of mRNA Vaccines
The European Medicines Agency (EMA) has released a draft guideline outlining " Quality standards for mRNA Vaccines " , f ocusing on...
Sharan Murugan
Apr 8, 20252 min read
SAHPRA Guideline: Section 21 Access to Unregistered Medicines
The South African Health Products Regulatory Authority (SAHPRA) has updated its Guideline " Section 21 Access to Unregistered Medicines "...
Sharan Murugan
Apr 6, 20253 min read
Swissmedic’s Guidance: Packaging, Prior Notification Procedures, Fast-Track Authorisation, Regulatory Meetings & Temporary Authorisations
Swissmedic, the Swiss Agency for Therapeutic Products, has released multiple updated guidance documents in April 2025 that impact...
Sharan Murugan
Apr 6, 20252 min read
EMA’s Reflection Paper: Linking to ePI from EU Medicine Packages – A Digital Leap in Patient Information
The European Medicines Agency (EMA) published on 31 March 2025 a draft " Reflection paper on linking to electronic Product Information...
Sharan Murugan
Apr 5, 20254 min read
UK MHRA Guidance: National Assessment Procedure for Medicines, Submission and Assessment timetables for Innovative Medicines Applications
The Medicines and Healthcare Products Regulatory Agency (MHRA) has introduced a " National Assessment Procedure for Medicines " for...
Sharan Murugan
Apr 3, 20252 min read
UK MHRA Guidance: Periodic Safety Update Reports (PSURs) for Medicinal Products
Ensuring the ongoing safety and efficacy of medicinal products is a cornerstone of pharmacovigilance. In the United Kingdom, the...
Sharan Murugan
Apr 1, 20253 min read
EMA's New AI Work Plan: Shaping the Future of Medicines Regulation
The European Medicines Agency (EMA) has unveiled a comprehensive Artificial Intelligence (AI) Work Plan to guide the integration of AI...
Sharan Murugan
Mar 31, 20252 min read
USFDA Guidance: Study Data Technical Conformance Guide – Technical Specifications Document and Data Standards Catalog
The U.S. Food and Drug Administration (FDA) has released the latest version (v6.0) of the Study Data Technical Conformance Guide in...
Sharan Murugan
Mar 30, 20253 min read
UK MHRA Guidance: Blue Guide -Advertising and Promoting Medicines – A Regulatory Overview
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated the Appendix 4 Best Practice Guidance of the " Blue Guide:...
Sharan Murugan
Mar 30, 20252 min read
EMA User Guide: For Micro, Small, and Medium-Sized Enterprises (SMEs)
The European Medicines Agency (EMA) has released a " User Guide for Micro, Small, and Medium-Sized Enterprises (SMEs) " to help...
Sharan Murugan
Mar 18, 20252 min read
SAHPRA Regulatory Information Management System (RIMS): Cancellation of Health Product Registrations for Non-eCTDs
The South African Health Products Regulatory Authority (SAHPRA) has issued a Communication to the industry " Regulatory Information...
Sharan Murugan
Mar 16, 20252 min read
EMA IRIS Guide for Applicants: A Comprehensive Overview
The European Medicines Agency (EMA) has released the updated " IRIS Guide for Applicants , " which provides detailed instructions on how...
Sharan Murugan
Mar 15, 20253 min read
MHRA Guidance: Good Clinical Practice (GCP) for Clinical Trials
The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on " Good Clinical Practice (GCP) for...
Sharan Murugan
Mar 15, 20253 min read
UK MHRA: Guidance on Regulation and Licensing of Advanced Therapy Medicinal Products (ATMPs) in the UK
To legally sell or supply an Advanced Therapy Medicinal Product (ATMP) in the United Kingdom, you must obtain a marketing authorisation...
Sharan Murugan
Mar 9, 20252 min read
Swissmedic Guidance: Renewal, Discontinuation, and Status Change of Medicinal Product Authorizations
The Swiss Agency for Therapeutic Products (Swissmedic) has released an updated guidance, " Renewal, Discontinuation, and Status Change of...
Sharan Murugan
Mar 3, 20252 min read
Swissmedic Guidance: Submission of PSUR/PBRER Submission for Human Medicinal Products
The Swiss Agency for Therapeutic Products (Swissmedic) has released an updated guidance" Submission of Periodic Safety Update Reports...
Sharan Murugan
Mar 3, 20252 min read
India CDSCO: Adding Trial Sites and Changing Principal Investigators
Clinical trials are a cornerstone of medical advancement, requiring meticulous planning and adherence to regulatory guidelines. In India,...
Sharan Murugan
Mar 3, 20253 min read
EMA Procedural Advice: Appointment of CHMP, CAT, and PRAC Rapporteurs and Co-Rapporteurs
The European Medicines Agency (EMA) has released an updated procedural guidance document on the " Appointment of CHMP, CAT, and PRAC...
Sharan Murugan
Feb 28, 20252 min read