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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 –...
Sharan Murugan
Aug 27, 20242 min read
190 views
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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...
Sharan Murugan
Jun 15, 20242 min read
18 views
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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"....
Sharan Murugan
Mar 29, 20242 min read
61 views
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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...
Sharan Murugan
Oct 1, 20231 min read
59 views
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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...
Sharan Murugan
Jun 27, 20231 min read
47 views
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Switzerland's SwissMedic: Guidance on Authorisation Biosimilar
Yesterday (21 June 2023) Switzerland's Swissmedic released an updated guidance on "Authorisation Biosimilar" which specifies the...
Sharan Murugan
Jun 22, 20231 min read
36 views
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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...
Sharan Murugan
Aug 2, 20221 min read
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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...
Sharan Murugan
Jan 16, 20221 min read
44 views
0 comments