Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

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 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 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

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 54 min read

UK MHRA Guidance: Exceptions and Modifications to the EU Good Pharmacovigilance Practices (GVP) for UK MAHs

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on pharmacovigilance requirements that...

Sharan Murugan

Feb 82 min read

EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation

The European Medicines Agency (EMA) provided detailed revised guidance "Procedural Advice for Orphan Medicinal Product Designation " for...

Sharan Murugan

Jan 262 min read

EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure

The European Medicines Agency (EMA) has issued comprehensive guidance " European Medicines Agency Pre-Authorisation Procedural Advice for...

Sharan Murugan

Dec 21, 20243 min read

EMA Guidance: Application of the Amended Variations Regulation from 1 January 2025

The European Medicines Agency (EMA) has updated its page on the " Application of the Amended Variations Regulation from 1 January 2025 "...

Sharan Murugan

Nov 1, 20242 min read

EMA IRIS Guide for Applicants: How to Create, Submit, and Manage IRIS Applications

On 16 September 2024 the European Medicines Agency (EMA) provided a detailed guide " IRIS guide for applicants - How to create and submit...

Sharan Murugan

Sep 21, 20242 min read

EMA Guidance: EudraVigilance Registration Manual

Yesterday the European Medicines Agency (EMA) provided an updated comprehensive guidance on EudraVigilance registration through its...

Sharan Murugan

Jul 20, 20242 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

EU Guidance: Procedural Advice on Paediatric Applications

The European Medicines Agency (EMA) provides detailed guidance "Procedural Advice on Paediatric Applications" that aims to facilitate the...

Sharan Murugan

Jul 11, 20242 min read

WHO: MeDevIS Platform and EU MDCG Guidance: Classification Rules for IVDs

WHO MeDevIS platform: The World Health Organization (WHO) has established the first global open access clearing house for medical device...

Sharan Murugan

Jul 10, 20242 min read

MDCG Med Dev Guidance: Standardisation for Medical Devices

The Medical Device Coordination Group recently updated the guidance"Standardisation for Medical Devices" include points on topics...

Sharan Murugan

Jul 6, 20242 min read

EMA Guidance: Procedural Advice on Paediatric Applications

The European Medicines Agency (EMA) yesterday(04 June 2024) updated and released the guidance document "Procedural Advice on Paediatric...

Sharan Murugan

Jun 5, 20242 min read

EMA Guidance: IRIS Guide for Applicants

On 03-June-2024 the European Medicines Agency released an updated "IRIS Guide for Applicants" that guides How to create, submit and...

Sharan Murugan

Jun 5, 20242 min read

EMA Guidance: EudraVigilance Registration Documents

The European Medicines Agency (EMA) on Thursday (16 May, 2024) released an updated guidance on "EudraVigilance Registration Documents"...

Sharan Murugan

May 18, 20242 min read

EMA: QRD updation and Product-Information Templates Updation

The European Medicines Agency released an updated template on QRD and updated its page on "Product-information templates - Human". The...

Sharan Murugan

Mar 2, 20242 min read

EMA Guidance: Electronic Submission of Information for Investigational Medicinal Products in XEVMPD

Recently (14 February 2024) the European Medicines Agency released updated (annotated) guidance on "Guidance on the electronic submission...

Sharan Murugan

Feb 17, 20242 min read