k.janecek2022-09-30T15:25:36+00:00February 4th, 2022|Categories: Clinical Trial, Europe, Regulatory, UK|Tags: Clinical Trial, Compliance, Europe, MHRA, Regulatory, Regulatory Affairs, UK|
UK: MHRA published guidance on clinical trial risk assessment, oversight and monitoring activities. The UK Medicines & Healthcare products Regulatory Agency (MHRA) has published guidance on clinical trial risk assessments, oversight and monitoring activities in two documents. It [...]
k.janecek2022-10-06T14:37:09+00:00July 19th, 2021|Categories: Clinical Trial, Europe, Regulatory, UK|Tags: Clinical Trial, Europe, MHRA, UK|
Europe – PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities (Revision 2) The Medicines and Healthcare products Regulatory Agency (MHRA) plans to streamline the review process for clinical trials of medicinal products concerning the changes brought by [...]
adminMTE_04792021-02-04T09:24:52+00:00February 4th, 2021|Categories: UK|Tags: Europe, MHRA, Regulatory, UK, UKCA|
The UK MHRA has updated a guidance on virtual manufacturing of medical devices. "A virtual manufacturer is an organisation that fully sources its own named product from another company [...] which has designed and manufactured an identical UKCA/CE/CE UKNI marked [...]
adminMTE_04792021-01-04T09:55:01+00:00January 4th, 2021|Categories: Compliance, Regulatory, UK|Tags: MHRA, UK|
As of 1 January, 2021 new relationships between the UK and the EU came into force. Among others this will impact the medtech industry with new requirements for market access and device registration. Meditrial offers market access and regulatory solutions [...]
adminMTE_04792020-12-01T10:35:47+00:00December 1st, 2020|Categories: Compliance, Regulatory, UK|Tags: European Union, MHRA, UK|
The UKCA (UK Conformity Assessed) marking will be the UK product marking that will be used for goods being placed on the market in Great Britain (England, Wales and Scotland) as of January 1st 2021. Meditrial offers market access and regulatory [...]
adminMTE_04792020-11-03T09:49:05+00:00November 3rd, 2020|Categories: Clinical Trial, Innovation, Software, UK|Tags: Clinical Trial, Digital Health, Innovation, MHRA, UK|
UK MHRA has issued a draft guidance on the use of real-world evidence (RWE) in clinical trials. The guidance is intended to support sponsors with planning clinical research and making regulatory decisions. MHRA exaplained that real-world data source in clinical [...]
adminMTE_04792020-08-14T07:59:07+00:00August 14th, 2020|Categories: Clinical Trial, Covid-19, UK|Tags: Clinical Trial, Covid-19, MHRA, UK|
MHRA issued a guidance including the plan to resume on-site inspections next September and scale up to full on-site inspection program in October 2020. Onsite inspections in the UK halted in March due to the COVID-19 pandemic. If you have [...]
k.janecek2020-05-22T08:43:52+00:00May 22nd, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, UK|Tags: Clinical Trial, Covid-19, Europe, MHRA, Regulatory, UK|
On 21 May 2020, NIHR set out a framework to guide the restarting of NIHR research activities which have been paused due to COVID-19. Sponsors planning to restart trials or to initiate new clinical trials should take account of the principles described [...]
adminMTE_04792020-05-20T09:00:57+00:00May 20th, 2020|Categories: Compliance, Covid-19, UK|Tags: Covid-19, MHRA, Regulatory, UK|
MHRA issued update to regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment). Contents Antimicrobial hand sanitisers and gels Face masks Gloves Offers to supply or donate healthcare equipment to the NHS/healthcare providers Failure [...]
k.janecek2020-05-08T13:30:32+00:00May 8th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, UK|Tags: Clinical Trial, Covid-19, Europe, MHRA, Regulatory, UK|
The Medicines and Healthcare products Regulatory Agency (MHRA) updated the guidance for industry on their flexible approaches to regulation during the COVID-19 outbreak. MHRA are working closely with the Department of Health and Social Care (DHSC) and other healthcare [...]
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