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UK MHRA Guidance: Medicines Pipeline Data and Pre-submission Advice & Support

The Medicines and Healthcare Products Regulatory Agency (MHRA) published a guidance on " Medicines Pipeline Data " on 13 August, 2024 to...

Sharan Murugan

Aug 15, 20242 min read

UK MHRA Guidance: Machine Learning Medical Devices: Transparency Principles

Last Thursday (13 June 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Machine...

Sharan Murugan

Jun 15, 20242 min read

UK MHRA: "AI Airlock" The Regulatory Sandbox for AIaMD

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced (09 May, 2024) the “AI Airlock - The Regulatory Sandbox...

Sharan Murugan

May 18, 20242 min read

UK MHRA: Guidance on Send and Receive information on Adverse Drug Reactions (ADRs)

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Send and Receive information on Adverse Drug...

Sharan Murugan

May 11, 20242 min read

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

Last Friday (03 May 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Software and...

Sharan Murugan

May 6, 20242 min read

UK MHRA: Notify MHRA About a Clinical Investigation for a Medical Device

Yesterday (26 April 2024) the UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Notify MHRA About a...

Sharan Murugan

Apr 27, 20242 min read

UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation

Yesterday (22 April 2024) the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance "Medicines: apply for a...

Sharan Murugan

Apr 22, 20242 min read

UK MHRA: Rolling Review for MAA and 150-Day Assessment for National Applications

Earlier today (16 April 2024) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on "Rolling Review for...

Sharan Murugan

Apr 16, 20242 min read

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

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Borderlines with Medical Devices & Other Products...

Sharan Murugan

Apr 13, 20242 min read

UK MHRA: Guidance on Regulation of devices in Northern Ireland & Apply for Manufacturer or Wholesaler of Medicines Licences

Earlier today (25 March 2025) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...

Sharan Murugan

Mar 25, 20242 min read

UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device

This week the Medicines and Healthcare Products Regulatory Agency (MHRA) updated multiple guidelines related to medicine and medical...

Sharan Murugan

Mar 20, 20242 min read

UK MHRA: Guidance on Established Medicines Marketing Authorisation Application Process Changes

The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance "Established Medicines Marketing Authorisation...

Sharan Murugan

Mar 13, 20241 min read

UK MHRA: Guidance on Packaging, Labelling and Patient Information Leaflets

Earlier today (08 March 2024) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its "Guidance on Medicines: Packaging,...

Sharan Murugan

Mar 7, 20242 min read

UK MHRA Guidance: Navigating on Applying for a Licence to Market a Medicine

Last Wednesday (28 February 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...

Sharan Murugan

Mar 2, 20242 min read

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