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Sharan Murugan
- Aug 27
- 2 min
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 15
- 2 min
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 29
- 2 min
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, 2023
- 1 min
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, 2023
- 1 min
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, 2023
- 1 min
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, 2022
- 1 min
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, 2022
- 1 min
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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