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Sharan Murugan
Aug 272 min read
UK MHRA Guidance: Clinical Trials for Medicines – Applying for Authorisation in the UK
The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated their comprehensive guidance " Clinical Trials for Medicines –...
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Sharan Murugan
Jun 152 min read
Swissmedic Guidance: Renewal and Discontinuation of Authorization or Change of Status (Main Authorization/Export License)
Swissmedic, the Swiss Agency for Therapeutic Products, has published comprehensive guidance "Renewal and Discontinuation of Authorization...
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Sharan Murugan
Mar 292 min read
Swiss Medic: eCTD Guidance for Industry & Time limits for Authorisation Applications
Swissmedic, recently published updated guidance on "Guidance Industry eCTD" and "Guidance on Time limits for Authorisation Applications"....
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Sharan Murugan
Oct 1, 20231 min read
MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)
On 29 September 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Northern Ireland...
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Sharan Murugan
Jun 27, 20231 min read
UK MHRA Guidance: Clinical Trials for Medicines: Apply for Authorisation in the UK
Yesterday (27 June 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...
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Sharan Murugan
Jun 22, 20231 min read
Switzerland's SwissMedic: Guidance on Authorisation Biosimilar
Yesterday (21 June 2023) Switzerland's Swissmedic released an updated guidance on "Authorisation Biosimilar" which specifies the...
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Sharan Murugan
Aug 2, 20221 min read
Swiss Medic Guidance: Authorisation Procedures for Covid-19 Medicinal products
Yesterday (01.08.2022) the Swiss Medic updated their "Guidance document on Authorisation procedures for Covid-19 medicinal products...
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Sharan Murugan
Jan 16, 20221 min read
UK Guidance on Clinical Trials: How to Apply for Authorization
UK MHRA updated its guidance on How to apply for a clinical trial including eligibility, phases, model IMPDs, costs, and how to make...
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