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USFDA Announcement: Shortening the Drug Approval Process- Integration of Generative AI by June end & Completion of First AI-Assisted Scientific Review
The U.S. Food and Drug Administration (FDA) has marked a significant milestone in its digital transformation journey by announcing the...
Sharan Murugan
May 13, 20252 min read
CIOMS Working Group Draft Report: Artificial Intelligence in Pharmacovigilance: Key Takeaways
The field of pharmacovigilance (PV) —the science of detecting, assessing, understanding, and preventing adverse effects or any other...
Sharan Murugan
May 13, 20253 min read
EMA Network Data Steering Group workplan 2025-2028: Leveraging Data and AI for Enhanced Medicine Regulation
In the evolving landscape of medicines regulation, data and artificial intelligence (AI) have become pivotal tools to enhance public and...
Sharan Murugan
May 11, 20253 min read
EMA Concept Paper: Advancements in Good Manufacturing Practice for Advanced Therapy Medicinal Products
The pharmaceutical industry continually evolves to adapt to new scientific discoveries and technological advancements. Good Manufacturing...
Sharan Murugan
May 11, 20253 min read
UK MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)
The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on " The Northern Ireland MHRA Authorised...
Sharan Murugan
May 11, 20252 min read
Swissmedic Guidelines: Formal Requirements & GMP Compliance for Foreign Manufacturers
When navigating Switzerland's regulatory landscape for medicinal products, two key guidance documents from Swissmedic stand out for their...
Sharan Murugan
May 3, 20253 min read
Swissmedic Guidance: Understanding Parallel Imports and the Authorisation of Asian Medicinal Products
Switzerland’s regulatory landscape for pharmaceuticals continues to evolve, balancing patient safety with market efficiency. Two pivotal...
Sharan Murugan
May 3, 20252 min read
Ireland HPRA’s Guide: Good Distribution Practice (GDP) of Medicinal Products
The Health Products Regulatory Authority (HPRA) of Ireland released Version 8 of its Guide to Good Distribution Practice (GDP) in March...
Sharan Murugan
May 3, 20253 min read
USFDA Public Consultation: HL7 FHIR for Study Data from Real-World Data
The U.S. Food and Drug Administration (FDA) has announced a major initiative by opening a public docket seeking comments on the "...
Sharan Murugan
Apr 27, 20253 min read
Australia's TGA Guidance Blog: Labelling and Presentation Requirements for Listed Medicines
On 9 April 2025, the Therapeutic Goods Administration (TGA) released updated guidance titled “ Understanding Labelling and Presentation...
Sharan Murugan
Apr 23, 20253 min read
SFDA Guidance: Requirements for Formal Meetings Between the Drug Sector and Applicants
Th e Saudi Food and Drug Authority (SFDA) has issued an updated version (3.1, dated 7 April 2025) of its guideline: " Requirements for...
Sharan Murugan
Apr 23, 20252 min read
ICH Guidance Q1: Stability Testing of Drug Substances and Drug Products (Step 2 Draft 2025)- Public Consultation
The International Council for Harmonisation (ICH) has released a significant update to its stability testing guidelines, consolidating...
Sharan Murugan
Apr 18, 20252 min read
EMA Guidance: Anonymisation and Confidentiality in Risk Management Plans (RMPs)
The European Medicines Agency (EMA) has published a revised guideline titled " Guidance on the Anonymisation of Protected Personal Data...
Sharan Murugan
Apr 18, 20254 min read
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
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