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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

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

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

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

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

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

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

EMA Procedural Advice: Recommendations on Unforeseen Variations

Earlier today (27 February 2023) European Medicine agency released an updated "Procedural Advice on Recommendations on unforeseen...

Sharan Murugan

Feb 27, 20231 min read

Finland's FIMEA: New/Updated (EU) MDCG Guidances to support Medical Device Operators

On 16 February 2023, the European Parliament approved the European Commission's proposal for amending the EU's Medical Device regulatory...

Sharan Murugan

Feb 25, 20231 min read

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

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

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

EMA Guidance: Anonymisation of PPD & CCI - Preparation of Risk Management Plans (RMP)

Today (04-November-2022) European Medicines Agency, released updated guidance on "Anonymisation of Protected Personal Data and assessment...

Sharan Murugan

Nov 4, 20221 min read

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

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

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

EMA Guidance: Checking process of Mock-ups & Specimens of Outer/Immediate Labelling & PI -CP

Earlier on 27th Spetmber, 2022 EMA revised and released their updated Regulatory and procedural guideline on "Checking process of...

Sharan Murugan

Sep 30, 20222 min read

IRIS Updated Guide: How to Create & Submit Scientific Applications & Accelerating Clin. Trials Plan

On 2-September, 2022 the European Medicines Agency released the updated IRIS guidance on "How to create and submit scientific...

Sharan Murugan

Sep 4, 20221 min read

EMA Guidance: For Applicants/MAHs involved in GMP and GCP Inspections

On August 31, 2022 the EMA updated its guidance "Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by...

Sharan Murugan

Sep 1, 20221 min read

EMA: Updated EudraVigilance Registration Manual

EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been...

Sharan Murugan

Aug 25, 20221 min read