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UK MHRA's Guidance: Software Applications (apps)
Recently the MHRA updated its Medical devices: Software Applications (apps) guidance, which provides information on when software...
Sharan Murugan
Sep 7, 20221 min read
UK MHRA's: Apply for a Parallel Import Licence (Guidance Update)
Today (17 August 2022) MHRA updated its Guidance on "Medicines: apply for a parallel import licence" The guidance in general details...
Sharan Murugan
Aug 17, 20221 min read
UK MHRA Guidance on: Manage your authorisation & Report Safety Issues
Today (9 August 2022) MHRA updated their Guidance on Clinical trials for medicines to manage authorisation, and report safety issues. The...
Sharan Murugan
Aug 9, 20221 min read
UK MHRA Guidance: Medicines: How to Reclassify your Product
Today (August 4, 2022) UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance for the industry, “Guidance:...
Sharan Murugan
Aug 4, 20221 min read
UK updated Guidance: Register Medical Devices to Place on the Market
Earlier this Thursday the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on how to register your medical...
Sharan Murugan
Jul 31, 20221 min read
UK MHRA's -Updated Guidance: How to Apply for Authorisation in the UK
Clinical trials for Medicines: Apply for Authorisation in the UK (18 July 2022) This updated guidance will detail how to apply for a...
Sharan Murugan
Jul 23, 20222 min read
UK MHRA: Guidance on "Advertise your Medicines"
The MHRA on 17-March-2022 updated its Guidance on Advertise your medicines which details how to comply with the requirements on promoting...
Sharan Murugan
Mar 23, 20221 min read
UK (MHRA) Project Orbis Guidance Update & New Guidance on Dialysis
Project Orbis aims to review and approve promising cancer treatments to help patients access treatment faster. MHRA recently added...
Sharan Murugan
Mar 13, 20221 min read
MHRA adds Health Technology Assessments (HTA) Tool Details to ILAP Guide
MHRA, the UK Medicines and Healthcare Products Regulatory Agency has updated its guidance information on the Innovative Licensing and...
Sharan Murugan
Mar 6, 20221 min read
Electronic Application Form and Cover Letter Tool - UK MHRA
On January 20, 2022, the UK MHRA released guidance on how to complete your Electronic Application Form (eAF) and Cover Letter. This form...
Sharan Murugan
Jan 23, 20221 min read
UK Guidance on Clinical Trials: How to Apply for Authorization
UK MHRA updated its guidance on How to apply for a clinical trial including eligibility, phases, model IMPDs, costs, and how to make...
Sharan Murugan
Jan 16, 20221 min read
Regulating Medical Devices & Place on The Market – UK
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. This guide...
Sharan Murugan
Jan 7, 20221 min read
Updated Guidance on Innovative Licensing and Access Pathway - MHRA
This new pathway supports innovative approaches to the safe, timely, and efficient development of medicines to improve patient access....
Sharan Murugan
Dec 21, 20211 min read
MHRA’s updated Guidance on URGENT SAFETY MEASURE – UK
This guidance has been developed to assist those involved in clinical trials disrupted as a result of COVID-19. It is relevant to those...
Sharan Murugan
Nov 20, 20211 min read
UK-MHRA Guidance on Pharmacovigilance Procedures
This guidance summarises UK-MHRA’s approach to pharmacovigilance. The Guidance on pharmacovigilance procedures was Updated on 14 October...
Sharan Murugan
Oct 19, 20211 min read
MHRA Guidance on need to Review Registration of Medical Devices
MHRA agency on 27 September 2021, provided the advice in an update to its guidance on "registering medical devices. MHRA has asked...
Sharan Murugan
Oct 3, 20211 min read
UK’s Updated Guidance on Managing Clinical Trials due to COVID-19 & Access to eHealth Records -MHRA
Managing clinical trials during Coronavirus (COVID-19) On 8th September 2021, MHRA updated the guidance on How investigators and sponsors...
Sharan Murugan
Sep 11, 20211 min read
MHRA's New & updated Innovative Licensing and Access Pathway - UK
A new pathway supporting innovative approaches to the safe, timely, and efficient development of medicines to improve patient access was...
Sharan Murugan
Aug 31, 20211 min read
Speedier Set Up for Clinical Research Trials – MHRA UK
The Medicines and Healthcare products Regulatory Agency (MHRA) is ensuring that the UK remains one of the best places in the world to...
Sharan Murugan
Jul 17, 20211 min read
MHRA Delivery Plan 2021-2023 – UK MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) publishes its Delivery Plan 2021-2023 ‘Putting patients first. This Plan...
Sharan Murugan
Jul 7, 20211 min read