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Sharan Murugan
Oct 222 min read
UK MHRA Guidance: Orphan Medicinal Products, Reference Medicinal Products (RMPs), and Handling of Active Substance Master Files (ASMFs) and Certificates of Suitability (CEP)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) on 18th october, 2024 updated multiple guidances such as " Orphan...
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Sharan Murugan
Jan 222 min read
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...
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Sharan Murugan
Oct 21, 20232 min read
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...
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Sharan Murugan
Jun 4, 20232 min read
SwissMedic Guidance: Orphan Drug, New Active Substance & Prior Notification
Swissmedic recently (02 June 2023) released multiple important guidelines that have captivated the audience and generated significant...
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Sharan Murugan
Nov 12, 20221 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...
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Sharan Murugan
Oct 3, 20211 min read
FDA’s finalized “Interpreting Sameness” Gene Therapy Products Guidance
USFDA on 29 September 2021, finalized "Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations". This guidance...
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