Search
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
3 days ago2 min read
16 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
11 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
14 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
25 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
26 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
22 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
39 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
55 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The Medicines and Healthcare products Regulatory Agency (MHRA) has recently initiated a public consultation on draft guidance for "...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
25 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
47 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
60 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
165 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
74 views
0 comments
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
41 views
0 comments
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
25 views
0 comments
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
24 views
0 comments
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
25 views
0 comments
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
24 views
0 comments
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
56 views
0 comments