Regulatory Blog

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EMA Publishes First EU eCTD v4.0 Validation Criteria and Updated Controlled Vocabularies

In 1st & 8th August 2025, the European Medicines Agency (EMA) announced two major milestones in the transition to electronic Common...

Sharan Murugan

Aug 102 min read

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 102 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 73 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 312 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 232 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 193 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 193 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 192 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 152 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 92 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 23 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 232 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 183 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 132 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 52 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 243 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 173 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 113 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 113 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 184 min read