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UK Med Dev Guidance: Clinical Investigations for Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA)Â has published detailed guidance " Clinical Investigation s " on...
Sharan Murugan
Dec 4, 20242 min read
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UK MHRA Press Release Trials Innovative AI Technologies in Regulatory Pilot Scheme
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â has launched (4th December 2024) a groundbreaking pilot scheme "...
Sharan Murugan
Dec 4, 20242 min read
29 views
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UK MHRA Issues Final Call to Comply with Windsor Framework for Medicines by January 2025
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â has issued " Call to comply with Windsor Framework arrangements for...
Sharan Murugan
Nov 30, 20242 min read
25 views
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UK MHRA Guidance: How Marketing Authorisation Applications referred under Article 29 are Handled
The UK MHRA updated its Guidance on " How Marketing Authorisation Applications referred under Article 29 are Handled " and outlines the...
Sharan Murugan
Nov 16, 20242 min read
26 views
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UK MHRA Guidance: Orphan Medicinal Products, Reference Medicinal Products (RMPs), and Handling of Active Substance Master Files (ASMFs) and Certificates of Suitability (CEP)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) on 18th october, 2024 updated multiple guidances such as " Orphan...
Sharan Murugan
Oct 22, 20242 min read
25 views
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UK MHRA Guidance: Conditional Marketing Authorisations, Exceptional Circumstances Marketing Authorisations, and National Scientific Advice
On 18th October, 2024 the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated their guidance on the processes related...
Sharan Murugan
Oct 22, 20242 min read
62 views
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UK MHRA Guidance: Pre-submission Advice & Support
UK's Medicines and Healthcare products Regulatory Agency (MHRA)Â updated and released ( 1 October 2024 ) guidance " Pre-Submission Advice...
Sharan Murugan
Oct 2, 20242 min read
29 views
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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
249 views
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UK MHRA Guidance: Apply for the Early Access to Medicines Scheme (EAMS)
The Medicines and Healthcare Products Regulatory Agency (MHRA) published guidance on "Apply for the early access to medicines scheme...
Sharan Murugan
Aug 18, 20242 min read
20 views
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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
31 views
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UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
On 22nd July 2024 the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued comprehensive guidance on " Good Clinical...
Sharan Murugan
Jul 23, 20242 min read
12 views
0 comments
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
13 views
0 comments
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
13 views
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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
110 views
0 comments
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
16 views
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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
7 views
0 comments
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
149 views
0 comments
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
221 views
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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
28 views
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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
32 views
0 comments