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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 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: 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 183 min read

EMA User Guide: For Micro, Small, and Medium-Sized Enterprises (SMEs)

The European Medicines Agency (EMA) has released a " User Guide for Micro, Small, and Medium-Sized Enterprises (SMEs) " to help...

Sharan Murugan

Mar 182 min read

EMA IRIS Guide for Applicants: A Comprehensive Overview

The European Medicines Agency (EMA) has released the updated " IRIS Guide for Applicants , " which provides detailed instructions on how...

Sharan Murugan

Mar 153 min read

EMA Procedural Advice: Appointment of CHMP, CAT, and PRAC Rapporteurs and Co-Rapporteurs

The European Medicines Agency (EMA) has released an updated procedural guidance document on the " Appointment of CHMP, CAT, and PRAC...

Sharan Murugan

Feb 282 min read

EMA Announcement: Regular Scientific Advice Procedure for High-Risk Medical Devices

In collaboration with the European Commission, the European Medicines Agency (EMA) has launched (10 February 2025) a regular...

Sharan Murugan

Feb 122 min read

New EU Regulations on AI in Medical Devices: Key Insights and Implications

The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...

Sharan Murugan

Jul 15, 20242 min read

EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making

On 12 April 2024 the European Medicines Agency released "Guidance on real-world evidence provided by EMA: support for regulatory...

Sharan Murugan

Apr 16, 20242 min read

EMA: Guidance on the Pharmaceutical Quality of Inhalation & Nasal Medicinal Products

Yesterday (12 April 2024) the European Medicines Agency released new guidance on "The Pharmaceutical Quality of Inhalation & Nasal...

Sharan Murugan

Apr 13, 20242 min read

EMA Guidance: Qualification of Novel Methodologies for Drug Development, Guidance to Applicants

Recently the European Medicines Agency released an updated guidance on "Qualification of Novel Methodologies for Drug Development:...

Sharan Murugan

Oct 10, 20232 min read

EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation

Recently this Friday (29-Sepetember, 2023), the European Commission's Clinical Trials Coordination and Advisory Group released an updated...

Sharan Murugan

Oct 1, 20232 min read

EMA Guidance: Compilation of Union Procedures on Inspections & Exchange of Information

Yesterday (14 July 2023) the European Medicines Agency released an updated regulatory and procedural guideline "Compilation of Union...

Sharan Murugan

Jul 15, 20231 min read

EMA Guideline: Notification of Serious Breaches or the Cinical Trial Protocol

Today (04 July 2023) the European Medicines Agency released a scientific guideline "Guideline for the notification of serious breaches of...

Sharan Murugan

Jul 4, 20232 min read

EMA Guidance: Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period

Earlier today (03 July 2023) the European Medicines Agency released updated guidance on "Guidance on Parallel EMA/HTA body (HTAb)...

Sharan Murugan

Jul 3, 20231 min read

EMA Guidance: Procedural Advice on Publication on Withdrawals of Applications related to MA

Today (27 June 2023), the European Medicines Agency released updated guidance on "Procedural Advice on Publication of Information on...

Sharan Murugan

Jun 27, 20231 min read

EMA Guidance: Paediatric Submissions Via Syncplicity Web Client

Recently on 09 June 2023, the European Medicines Agency released updated guidance on "Paediatric Submissions Via Syncplicity Web Client"....

Sharan Murugan

Jun 17, 20231 min read

EMA Guidance: Good Practices for Industry for the Prevention of Human Medicinal Product Shortages

Earlier today (17 May 2023) the European Medicines Agency released an updated guidance document on "Good Practices for Industry for the...

Sharan Murugan

May 18, 20231 min read

EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS

Last Week (03 May 2023) the European Medicines Agency released an Interim guidance document on "How to Approach the Protection of...

Sharan Murugan

May 7, 20232 min read