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UK MHRA Guidance: Risk Minimisation Measures for Medicines
The Medicines and Healthcare products Regulatory Agency (MHRA)Â has published updated guidance on " Risk Minimisation Measures (RMMs)Â for...
Sharan Murugan
9 hours ago2 min read
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UK MHRA Guidance: How to Notify a Clinical Investigation for a Medical Device & CTR Signed to Law
Before starting any clinical investigation involving a medical device in the UK, it is a legal requirement to notify the Medicines and...
Sharan Murugan
10 hours ago3 min read
3 views
0 comments
UK MHRA Guidance: National Assessment Procedure for Medicines, Submission and Assessment timetables for Innovative Medicines Applications
The Medicines and Healthcare Products Regulatory Agency (MHRA)Â has introduced a " National Assessment Procedure for Medicines " Â for...
Sharan Murugan
Apr 32 min read
30 views
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UK MHRA Guidance: Periodic Safety Update Reports (PSURs) for Medicinal Products
Ensuring the ongoing safety and efficacy of medicinal products is a cornerstone of pharmacovigilance. In the United Kingdom, the...
Sharan Murugan
Apr 13 min read
31 views
0 comments
UK MHRA: Guidance for Established Medicines -Marketing Authorisation Application Changes
The regulatory landscape for pharmaceuticals is constantly evolving, and the UK Medicines and Healthcare products Regulatory Agency...
Sharan Murugan
Apr 12 min read
21 views
0 comments
UK MHRA Guidance: Blue Guide -Advertising and Promoting Medicines – A Regulatory Overview
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â has updated the Appendix 4 Best Practice Guidance of the " Blue Guide:...
Sharan Murugan
Mar 302 min read
13 views
0 comments
MHRA Guidance: Registering to Manufacture, Import, or Distribute Active Substances
The Medicines and Healthcare products Regulatory Agency (MHRA)Â has established guidelines " Medicines: Register to manufacture, import...
Sharan Murugan
Mar 262 min read
26 views
0 comments
MHRA Guidance: Good Clinical Practice (GCP) for Clinical Trials
The Medicines and Healthcare Products Regulatory Agency (MHRA)Â has released updated guidance on " Good Clinical Practice (GCP)Â for...
Sharan Murugan
Mar 153 min read
13 views
0 comments
UK Medical Device Regulations: Registration and Export Guidelines
Earlier today the Medicines and Healthcare products Regulatory Agency (MHRA)Â released updated guidance " Register medical devices to...
Sharan Murugan
Mar 133 min read
22 views
0 comments
UK MHRA: Guidance on Regulation and Licensing of Advanced Therapy Medicinal Products (ATMPs) in the UK
To legally sell or supply an Advanced Therapy Medicinal Product (ATMP) in the United Kingdom, you must obtain a marketing authorisation...
Sharan Murugan
Mar 92 min read
30 views
0 comments
Navigating UK MHRA Guidance: Registration and Regulation of Medical Devices in the UK
The Medicines and Healthcare Products Regulatory Agency (MHRA) Â oversees the regulation and registration of medical devices within the...
Sharan Murugan
Feb 182 min read
30 views
0 comments
UK MHRA Guidance: Software and AI as a Medical Device
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â updated its guidance on Software and Artificial Intelligence (AI) as a...
Sharan Murugan
Feb 92 min read
25 views
0 comments
UK MHRA Guidance: Managing Clinical Trial Authorisations & Safety Reporting (Updated 2025)
The UK Medicines and Healthcare products Regulatory Agency (MHRA)Â has updated its guidance on " Clinical trials for medicines: manage...
Sharan Murugan
Feb 92 min read
71 views
0 comments
UK MHRA Guidance: Exceptions and Modifications to the EU Good Pharmacovigilance Practices (GVP) for UK MAHs
The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on pharmacovigilance requirements that...
Sharan Murugan
Feb 82 min read
61 views
0 comments
UK MHRA Draft Guideline: Individualised mRNA Cancer Immunotherapies
The Medicines and Healthcare products Regulatory Agency (MHRA) has recently initiated a public consultation on draft guidance for "...
Sharan Murugan
Feb 52 min read
12 views
0 comments
UK MHRA Guidance: Regulatory Framework for Licensing, Importing, and Supplying Medicines in the UK
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â has issued several guidance documents detailing the licensing,...
Sharan Murugan
Feb 13 min read
40 views
0 comments
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...
Sharan Murugan
Jan 22 min read
51 views
0 comments
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...
Sharan Murugan
Dec 21, 20242 min read
67 views
0 comments
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...
Sharan Murugan
Dec 21, 20242 min read
212 views
0 comments
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...
Sharan Murugan
Dec 15, 20242 min read
97 views
0 comments