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MHRA Guidance: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing

Nitrosamines have become a significant concern in the pharmaceutical industry due to their potential carcinogenicity. In response to this...

Sharan Murugan

Jan 18, 20242 min read

MHRA Guidance: Notify the MHRA about a Clinical Investigation for a Medical Device

Earlier today (17 July, 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Notify the...

Sharan Murugan

Jan 16, 20242 min read

UK MHRA: Guidance on 150-Day Assessment for National Applications for Medicines

Earlier today (05 January 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "150-day...

Sharan Murugan

Jan 5, 20242 min read

UK MHRA: Guidance on Operational Information Sharing

Earlier today (02 January 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Operational...

Sharan Murugan

Jan 2, 20241 min read

UK MHRA: Guidance on Submitting Changes to Labelling and Patient Information Leaflets

On 22nd December 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Medicines "Submitting...

Sharan Murugan

Dec 27, 20232 min read

UK MHRA Guidance: Apply for a Parallel Import Licence

Earlier today (05 December 2023) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Medicines: "Apply for...

Sharan Murugan

Dec 5, 20232 min read

UK MHRA: Guidance on Register Medical Devices to Place on the Market

Last Friday on 1st December 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Register...

Sharan Murugan

Dec 3, 20231 min read

UK MHRA: Guidance on Change of Ownership: Marketing Authorisation Process

Last Friday (17 November 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Medicines...

Sharan Murugan

Nov 18, 20232 min read

MHRA Guidance: Common Issues Identified during Clinical Trial Applications

Yesterday (06 November 2023) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Common...

Sharan Murugan

Nov 7, 20231 min read

UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device

Earlier today (25 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Software...

Sharan Murugan

Oct 25, 20231 min read

UK MHRA Guidance: Apply for a Licence to Market a Medicine in the UK

Last Thursday (19 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for a...

Sharan Murugan

Oct 21, 20231 min read

UK MHRA: Clinical Trials for Medicines: Apply for Authorisation in the UK

Recently (12 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...

Sharan Murugan

Oct 14, 20232 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...

Sharan Murugan

Oct 1, 20231 min read

MHRA MD Guidance: Innovative Devices Access Pathway (IDAP) & How to Notify Clinical Investigation

Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Innovative Devices Access...

Sharan Murugan

Sep 25, 20232 min read

UK MHRA: Guidance on International Recognition Procedure

Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released a guidance on "International Recognition Procedure"...

Sharan Murugan

Sep 9, 20231 min read

UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime

Guidance on Renewing Marketing Authorisations Recently (28, July 2023) the UK's Medicines and Healthcare Products Regulatory Agency...

Sharan Murugan

Jul 30, 20231 min read

UK MHRA: Guidance on Labelling & Packaging of Medicinal Products - Windsor Framework

On 27 July 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Labelling and packaging of...

Sharan Murugan

Jul 30, 20232 min read

MHRA Med Dev Guidance: In-Vitro Diagnostic Medical Devices on Legislation

Earlier today (17 July, 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The...

Sharan Murugan

Jul 17, 20231 min read

UK MHRA MD Guidance: Borderlines with Medical Devices & Other Products in Great Britain

Yesterday(01 July 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidelines on the "Borderlines...

Sharan Murugan

Jul 2, 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...

Sharan Murugan

Jun 27, 20231 min read