Search
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 82 min read
12 views
0 comments
SAHPRA Guideline: Section 21 Access to Unregistered Medicines
The South African Health Products Regulatory Authority (SAHPRA)Â has updated its Guideline " Section 21 Access to Unregistered Medicines "...
Sharan Murugan
Apr 63 min read
27 views
0 comments
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 62 min read
8 views
0 comments
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 54 min read
16 views
0 comments
UK MHRA Guidance: National Assessment Procedure for Medicines, Submission and Assessment timetables for Innovative Medicines Applications
The Medicines and Healthcare Products Regulatory Agency (MHRA)Â has introduced a " National Assessment Procedure for Medicines " Â for...
Sharan Murugan
Apr 32 min read
25 views
0 comments
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 13 min read
30 views
0 comments
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 312 min read
24 views
0 comments
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 303 min read
49 views
0 comments
UK MHRA Guidance: Blue Guide -Advertising and Promoting Medicines – A Regulatory Overview
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â has updated the Appendix 4 Best Practice Guidance of the " Blue Guide:...
Sharan Murugan
Mar 302 min read
13 views
0 comments
EMA User Guide: For Micro, Small, and Medium-Sized Enterprises (SMEs)
The European Medicines Agency (EMA)Â has released a " User Guide for Micro, Small, and Medium-Sized Enterprises (SMEs) "Â to help...
Sharan Murugan
Mar 182 min read
15 views
0 comments
SAHPRA Regulatory Information Management System (RIMS): Cancellation of Health Product Registrations for Non-eCTDs
The South African Health Products Regulatory Authority (SAHPRA)Â has issued a Communication to the industry " Regulatory Information...
Sharan Murugan
Mar 162 min read
24 views
0 comments
EMA IRIS Guide for Applicants: A Comprehensive Overview
The European Medicines Agency (EMA)Â has released the updated " IRIS Guide for Applicants , " which provides detailed instructions on how...
Sharan Murugan
Mar 163 min read
28 views
0 comments
MHRA Guidance: Good Clinical Practice (GCP) for Clinical Trials
The Medicines and Healthcare Products Regulatory Agency (MHRA)Â has released updated guidance on " Good Clinical Practice (GCP)Â for...
Sharan Murugan
Mar 153 min read
13 views
0 comments
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 92 min read
29 views
0 comments
Swissmedic Guidance: Renewal, Discontinuation, and Status Change of Medicinal Product Authorizations
The Swiss Agency for Therapeutic Products (Swissmedic)Â has released an updated guidance, " Renewal, Discontinuation, and Status Change of...
Sharan Murugan
Mar 32 min read
22 views
0 comments
Swissmedic Guidance: Submission of PSUR/PBRER Submission for Human Medicinal Products
The Swiss Agency for Therapeutic Products (Swissmedic)Â has released an updated guidance" Submission of Periodic Safety Update Reports...
Sharan Murugan
Mar 32 min read
31 views
0 comments
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 33 min read
9 views
0 comments
EMA Procedural Advice: Appointment of CHMP, CAT, and PRAC Rapporteurs and Co-Rapporteurs
The European Medicines Agency (EMA)Â has released an updated procedural guidance document on the " Appointment of CHMP, CAT, and PRAC...
Sharan Murugan
Mar 12 min read
25 views
0 comments
MHRA Guidance: Format and Content of Applications for Agreement or Modification of a Paediatric Investigation Plan
The Medicines and Healthcare products Regulatory Agency (MHRA)Â has established comprehensive guidelines detailing the " Format and...
Sharan Murugan
Feb 282 min read
23 views
0 comments
EMA Addendum: Clinical Development of Vaccines in Immunocompromised Individuals
The European Medicines Agency (EMA) has released an addendum to its Guideline on the " Clinical Development of Vaccines to address the...
Sharan Murugan
Feb 272 min read
11 views
0 comments