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UK MHRA Guidance: Software and AI as a Medical Device

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Software and Artificial Intelligence (AI) as a...

Sharan Murugan

Feb 92 min read

UK MHRA Guidance: Managing Clinical Trial Authorisations & Safety Reporting (Updated 2025)

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on " Clinical trials for medicines: manage...

Sharan Murugan

Feb 92 min read

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

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The Medicines and Healthcare products Regulatory Agency (MHRA) has recently initiated a public consultation on draft guidance for "...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

UK MHRA Guidance: Regulatory Framework for Licensing, Importing, and Supplying Medicines in the UK

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued several guidance documents detailing the licensing,...

Sharan Murugan

Feb 13 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...

Sharan Murugan

Jan 22 min read

UK MHRA: Guidance on the Licensing of Biosimilar Products

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the " Licensing of Biosimilar Products " in...

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...

Sharan Murugan

Dec 21, 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) has published updated guidance " Applying for a Licence to Market a...

Sharan Murugan

Dec 15, 20242 min read

UK Med Dev Guidance: Clinical Investigations for Medical Devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has published detailed guidance " Clinical Investigation s " on...

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) has launched (4th December 2024) a groundbreaking pilot scheme "...

Sharan Murugan

Dec 4, 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) has issued " Call to comply with Windsor Framework arrangements for...

Sharan Murugan

Nov 29, 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...

Sharan Murugan

Nov 16, 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...

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...

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