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Swissmedic’s Clinical Trial Guidance Suite: Everything Sponsors Need to Know
On June 2, 2025 , Swissmedic published a harmonised suite of guidance documents to standardise, streamline, and digitalise the clinical...
Sharan Murugan
Jun 7, 20252 min read
USFDA Guidance: M11 Technical Specification & Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
In a major step toward global harmonisation of clinical trial processes, the U.S. Food and Drug Administration (FDA) and the...
Sharan Murugan
Jun 7, 20252 min read
EMA Guidance: Core SmPC Guideline for Subcutaneous and Intramuscular Immunoglobulins: What Manufacturers Need to Know
Human normal immunoglobulin (IgG) products administered via the subcutaneous (SCIg) or intramuscular (IMIg) route are essential...
Sharan Murugan
Jun 5, 20252 min read
Meet ELSA: USFDA Launches Agency-Wide AI Tool to Optimize Performance
What if the agonizing wait for drug approvals could be slashed from days to minutes? Imagine a future where breakthrough therapies reach...
Sharan Murugan
Jun 2, 20252 min read
EMA Guidance: EudraVigilance Registration Manual -Step-by-Step Guide to Compliance and Signal Management
Pharmacovigilance is critical for ensuring drug safety in the EU. EudraVigilance is the central system operated by the European Medicines...
Sharan Murugan
May 24, 20253 min read
UK MHRA's Guidance: Use of Real-World Data in Clinical Studies for Regulatory Decisions
The integration of real-world data (RWD) in clinical research is revolutionizing the pharmaceutical landscape. The Medicines and...
Sharan Murugan
May 22, 20252 min read
UK MHRA Guidance: Navigating the UK National Assessment
Understanding and navigating the UK's regulatory requirements is crucial for pharmaceutical companies aiming to obtain marketing...
Sharan Murugan
May 22, 20252 min read
Swissmedic’s Guidance: Authorisation of Co-Marketing Medicinal Products
Companies increasingly turn to co-marketing partnerships in today’s highly competitive pharmaceutical landscape to expand product reach,...
Sharan Murugan
May 21, 20252 min read
EMA Policy 0070 Guidance: Transparency in Clinical Data Publication – Version 1.5 (May 2025)
The European Medicines Agency (EMA) has long committed to this principle through Policy 0070, which governs the publication of clinical...
Sharan Murugan
May 17, 20253 min read
UK MHRA Guidance: International Recognition Procedure – Streamlining Access to Medicines in Great Britain
In a globally interconnected pharmaceutical landscape, regulatory collaboration is essential to ensure timely patient access to safe and...
Sharan Murugan
May 17, 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
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
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