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EMA Procedural Advice: Paediatric Applications – A Comprehensive Guide for Applicants
On 8 August 2025 , the European Medicines Agency (EMA)Â published the latest revision (Rev. 14) of its "Procedural Advice on Paediatric...

Sharan Murugan
Aug 102 min read
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UK MHRA Guidance: Pre-submission Advice & Support
UK's Medicines and Healthcare products Regulatory Agency (MHRA)Â updated and released ( 1 October 2024 ) guidance " Pre-Submission Advice...

Sharan Murugan
Oct 2, 20242 min read
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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 1, 20231 min read
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