Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

EMA Guidance: EudraVigilance Registration Manual

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

Sharan Murugan

Jul 19, 20242 min read

EMA Guidance: Proposed Amendments - Variations Categories and Procedures

The European Medicines Agency (EMA) has proposed amendments to the European Commission's "Guidelines on Variations Categories and...

Sharan Murugan

Jun 15, 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 17, 20242 min read

EMA: Guidance on the Anonymisation of PPD & Assessment of CCI during the preparation of RMPs

The European Medicines Agency (EMA) yesterday (26 April, 2024) released an updated guidance on the "Anonymisation of protected personal...

Sharan Murugan

Apr 27, 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: e-Submission of Information on IMP in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)

The European Medicines Agency (EMA) last Wednesday released an updated guidance on the electronic submission of information on...

Sharan Murugan

Mar 25, 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

EMA Guidance: Applying for Orphan Designation, IRIS Guide & Orphan Des Procedural Guidance & Forms

Recently (19 January 2023) the European Medicines Agency released an updated guidance on "IRIS guide for applicants - How to create and...

Sharan Murugan

Jan 22, 20242 min read

EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation

Yesterday (20 October 2023) the European Medicines Agency released an updated guidance on "Procedural Advice for Orphan Medicinal Product...

Sharan Murugan

Oct 21, 20232 min read

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

Yesterday (13 October 2023) the European Medicines Agency released an updated guidance on "European Medicines Agency post-authorisation...

Sharan Murugan

Oct 14, 20231 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: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure

Last Friday (29 September 2023) the European Medicines Agency released an updated guidance on "European Medicines Agency...

Sharan Murugan

Oct 1, 20231 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