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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 –...

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...

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"....

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...

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...

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...

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...

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...