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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
230 views
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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
21 views
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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
220 views
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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
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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
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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
69 views
0 comments
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
200 views
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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
106 views
0 comments
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
49 views
0 comments
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
33 views
0 comments
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
194 views
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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: 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 2, 20231 min read
35 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