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Sharan Murugan
Jan 22 min read
UK MHRA Guidance: 150-Day Assessment for National Applications for Medicines & Procedures for UK Paediatric Investigation Plans (PIPs)
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) continues to innovate in the regulatory space with updated processes...
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Sharan Murugan
Dec 21, 20242 min read
UK MHRA: Guidance on the Licensing of Biosimilar Products
The Medicines and Healthcare products Regulatory Agency (MHRA)Â has updated its guidance on the " Licensing of Biosimilar Products "Â in...
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Sharan Murugan
Dec 21, 20242 min read
UK MHRA Guidance: Variations to Marketing Authorisations (MAs)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published (20 December 2024) updated guidance " Variations to...
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Sharan Murugan
Dec 15, 20242 min read
UK MHRA Guidance: Applying for a Licence to Market a Medicine in the UK
The Medicines and Healthcare Products Regulatory Agency (MHRA) Â has published updated guidance " Applying for a Licence to Market a...
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Sharan Murugan
Dec 4, 20242 min read
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...
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Sharan Murugan
Dec 4, 20242 min read
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 "...
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Sharan Murugan
Nov 29, 20242 min read
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...
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Sharan Murugan
Nov 16, 20242 min read
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...
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Sharan Murugan
Oct 22, 20242 min read
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...
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Sharan Murugan
Oct 22, 20242 min read
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...
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Sharan Murugan
Oct 2, 20242 min read
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...
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Sharan Murugan
Sep 28, 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...
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Sharan Murugan
Sep 15, 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 &...
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Sharan Murugan
Aug 27, 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 –...
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Sharan Murugan
Aug 18, 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...
17 views0 comments
Sharan Murugan
Aug 15, 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...
29 views0 comments
Sharan Murugan
Jun 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...
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Sharan Murugan
May 18, 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...
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Sharan Murugan
May 11, 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...
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Sharan Murugan
May 6, 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...
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