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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
3 days ago3 min read
2 views
0 comments
EMA User Guide: For Micro, Small, and Medium-Sized Enterprises (SMEs)
The European Medicines Agency (EMA)Â has released a " User Guide for Micro, Small, and Medium-Sized Enterprises (SMEs) "Â to help...
Sharan Murugan
Mar 182 min read
16 views
0 comments
EMA IRIS Guide for Applicants: A Comprehensive Overview
The European Medicines Agency (EMA)Â has released the updated " IRIS Guide for Applicants , " which provides detailed instructions on how...
Sharan Murugan
Mar 163 min read
29 views
0 comments
EMA Procedural Advice: Appointment of CHMP, CAT, and PRAC Rapporteurs and Co-Rapporteurs
The European Medicines Agency (EMA)Â has released an updated procedural guidance document on the " Appointment of CHMP, CAT, and PRAC...
Sharan Murugan
Mar 12 min read
26 views
0 comments
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
13 views
0 comments
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
84 views
0 comments
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
42 views
0 comments
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
89 views
0 comments
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
60 views
0 comments
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 2, 20232 min read
116 views
0 comments
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
355 views
0 comments
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
824 views
0 comments
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
67 views
0 comments
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
324 views
0 comments
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
69 views
0 comments
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
52 views
0 comments
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
332 views
0 comments
EMA Guidance: Pre & Post Authorisation for Users of the Centralised Procedure
Recently this week (25 April, 20223) the European Medicines Agency updated and released the guidances on "Pre-authorisation procedural...
Sharan Murugan
Apr 29, 20231 min read
38 views
0 comments
EMA Guidance: IRIS guide to Registration and Research Product Identifiers
Last Week (20 April 2023) the European Medicines Agency updated and released the guidance on "IRIS guide to Registration and RPIs" which...
Sharan Murugan
Apr 23, 20231 min read
182 views
0 comments
EMA Guideline: Computerised Systems & Electronic Data in Clinical Trials
Recently (9 March 2023) the European Medicine agency released a "Guideline on Computerised Systems & Electronic Data in Clinical Trials"...
Sharan Murugan
Mar 11, 20231 min read
205 views
0 comments