Search
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
UK MHRA Guidance: Pre-submission Advice & Support
UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated and released ( 1 October 2024 ) guidance " Pre-Submission Advice...
Sharan Murugan
Oct 2, 20242 min read
UK MHRA: Guidance on Applying for a Manufacturer or Wholesaler of Medicines Licence
Yesterday (27 September 2024) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on " Applying...
Sharan Murugan
Sep 28, 20242 min read
UK MHRA: Windsor Framework: Wholesalers & Manufacturers Guidance & Labelling and Packaging Requirements
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released 2 updated essential guidances " Wholesalers &...
Sharan Murugan
Sep 15, 20242 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 –...
Sharan Murugan
Aug 27, 20242 min read
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
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