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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
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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
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
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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
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
EMA Checklist: Updated Validation checklist for Type II quality variations
Recently on 10th February 2023, the European Medicines Agency (EMA) updated and released their "Validation checklist for Type II quality...
Sharan Murugan
Feb 14, 20231 min read
321 views
0 comments
EMA Guidance: Format & Validity Features of e-Certificates and How to Fll the Application Form
Yesterday (16-January-2023) European Medicines Agency (EMA) released an udated guideline "Information note on the format and validity...
Sharan Murugan
Jan 16, 20232 min read
70 views
0 comments
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
On 11 November 2022, the European medicines agency released updated guidance for sponsors about the "Procedural Advice for Orphan...
Sharan Murugan
Nov 12, 20221 min read
35 views
0 comments
EMA Guidance: Pre & Post-Authorisation Procedural Advice for Users of the Centralised Procedure
Earlier today (04-November-2022) the European Medicines Agency (EMA) released updated guidance on "Pre-Authorisation Procedural Advice...
Sharan Murugan
Nov 4, 20221 min read
433 views
0 comments
EMA Guidance: Scientific Advice and Protocol Assistance
European Medicines Agency (EMA) recently updated (14-October-2022) its guidance on "Scientific advice and protocol assistance" and also...
Sharan Murugan
Oct 17, 20221 min read
285 views
0 comments
EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations
Recently EMA released an updated guidance document for the purpose of simplifying the completion of the application form process for...
Sharan Murugan
Oct 13, 20221 min read
214 views
0 comments