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Sharan Murugan
Jan 7, 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...
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Sharan Murugan
Dec 21, 20211 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....
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Sharan Murugan
Nov 20, 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...
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Sharan Murugan
Oct 19, 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...
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Sharan Murugan
Oct 3, 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...
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Sharan Murugan
Sep 11, 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...
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Sharan Murugan
Aug 31, 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...
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Sharan Murugan
Jul 17, 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...
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Sharan Murugan
Jul 7, 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...
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Sharan Murugan
Jul 7, 20211 min read
Phase I Accreditation Scheme - UK MHRA
The MHRA phase I accreditation scheme is a voluntary scheme for organisations conducting phase I trials, for those conducting first in...
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Sharan Murugan
Jun 30, 20211 min read
Clinical trials: Apply for authorisation in UK – MHRA
This is a recently updated guidance that discusses How to apply for a clinical trial including eligibility, phases, model IMPDs, costs,...
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Sharan Murugan
May 10, 20211 min read
First authorisation under Project Orbis - UK MHRA
Project Orbis is an innovative programme coordinated by the US Food and Drug Administration (FDA) with Canada, Australia, Switzerland,...
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Sharan Murugan
May 8, 20211 min read
Guidance on the Licensing of Biosimilar Products - United Kingdom (MHRA)
What is a Biosimilar Medicine? Biosimilar medicine is a biological medicine that is developed to be highly similar and clinically...
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