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EMA Procedural Advice: Paediatric Applications – A Comprehensive Guide for Applicants
On 8 August 2025 , the European Medicines Agency (EMA) published the latest revision (Rev. 14) of its "Procedural Advice on Paediatric...
Sharan Murugan
Aug 10, 20252 min read
EMA’s Feedback: On Replacing Titanium Dioxide (TiO₂) in Medicinal Products: Critical Challenges, Limited Alternatives (Human & Veterneary)
The European Medicines Agency (EMA) submitted its updated report to the European Commission (EC) evaluating the feasibility of...
Sharan Murugan
Aug 7, 20253 min read
EMA Guidance: Procedural Advice on Paediatric Applications
On 25 July 2025 , the European Medicines Agency (EMA) published the latest guidance " Procedural Advice on Paediatric Applications " ....
Sharan Murugan
Jul 31, 20252 min read
EMA Guidance: Requirements for Demonstrating Therapeutic equivalence between Orally Inhaled Products (OIP) and Chronic Obstructive Pulmonary Disease (COPD)
On 14 July 2025 , the European Medicines Agency (EMA) published the final revised guideline titled " Guideline on the requirements for...
Sharan Murugan
Jul 23, 20252 min read
European Commission: Guidelines on the Scope of the Obligations for General-Purpose AI Models established by AI Act
On 18 July 2025, the European Commission published detailed Guidelines on the scope of the obligations for providers of general-purpose...
Sharan Murugan
Jul 19, 20253 min read
EMA’s AI Journey: The Rise of Artificial Intelligence in Medicines Regulation
In a world where artificial intelligence (AI) is moving rapidly from theory to practice, regulators are tasked with keeping pace—not only...
Sharan Murugan
Jul 19, 20253 min read
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
The European Medicines Agency (EMA) provides structured guidance for sponsors aiming to secure orphan medicinal product designation...
Sharan Murugan
Jul 19, 20252 min read
EMA IRIS Guide: How to Create, Submit and Manage IRIS applications, for Industry and Individual applicants
In the ever-evolving regulatory landscape of EU pharmaceuticals, digital solutions are a linchpin for timely and transparent scientific...
Sharan Murugan
Jul 15, 20252 min read
EMA’s CTIS Framework: Decoding the EMA Clinical Trial Information System-A Practical Guide for Sponsors
In an era of data-driven drug development, the European Medicines Agency (EMA) has launched a transformative regulatory framework : the...
Sharan Murugan
Jul 9, 20252 min read
EMA NDSG Work Plan: Inside the Network Data Steering Group Workplan 2025–2028
In an era where data drives decisions and innovation defines progress, the European Medicines Agency (EMA) and Heads of Medicines...
Sharan Murugan
Jul 2, 20253 min read
EMA Guidance: EMA’s Implementation of ISO IDMP Standards Through Products Management Services (PMS)
To modernize and harmonize the management of medicinal product information, the European Medicines Agency (EMA) is actively implementing...
Sharan Murugan
Jun 23, 20252 min read
EMA Guidance: A Guide to the HMA-EMA Real-World Evidence Catalogues
As the role of real-world data (RWD) and real-world evidence (RWE) grows in drug development, regulatory decision-making, and...
Sharan Murugan
Jun 18, 20253 min read
EMA’s User Guide: HMA-EMA Catalogues of Real-World Data Sources and Studies
The integration of real-world data (RWD) into regulatory decision-making is transforming the landscape of pharmaceutical development and...
Sharan Murugan
Jun 13, 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
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
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
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
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