UK: MHRA published guidance on clinical trial risk assessment, oversight and monitoring activities.

2024-02-29T16:24:13+00:00February 4th, 2022|Categories: Clinical Trial, Europe, Regulatory, UK|Tags: , , , , , , |

The UK Medicines & Healthcare products Regulatory Agency (MHRA) has published guidance on clinical trial risk assessments, oversight and monitoring activities in two documents. It aims to assist sponsors and those conducting trials on implementing adequate oversight and monitoring [...]

MHRA announces combined review of clinical trials for medicinal products

2023-03-29T15:54:25+00:00July 19th, 2021|Categories: Clinical Trial, Europe, Regulatory, UK|Tags: , , , |

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 Brexit. As of January 2022, new Clinical Trials of Investigational Medicinal Products (CTIMPs) will [...]

UK: MHRA updates guidance on virtual manufacturing of medical devices

2024-02-29T16:27:55+00:00February 4th, 2021|Categories: UK|Tags: , , , , |

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 [...]

Post-BREXIT EU relations with the United Kingdom and impact on medical devices

2024-02-29T14:05:00+00:00January 4th, 2021|Categories: Compliance, Regulatory, UK|Tags: , |

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 [...]

UK: Get ready for UK market access and the new UKCA requirements

2023-03-31T16:32:08+00:00December 1st, 2020|Categories: Compliance, Regulatory, UK|Tags: , , |

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 [...]

UK: MHRA supports generating RWE in clinical trials through digital solutions

2024-02-29T16:25:13+00:00November 3rd, 2020|Categories: Clinical Trial, Innovation, Software, UK|Tags: , , , , |

UK MHRA has issued a draft guidance on the use of real-world evidence (RWE) in clinical trials.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 [...]

UK: MHRA plans to restart on-site inspections as of September 2020

2024-02-29T16:01:48+00:00August 14th, 2020|Categories: Clinical Trial, Covid-19, UK|Tags: , , , |

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 [...]

UK: Managing clinical trials during COVID-19

2024-02-29T15:17:32+00:00May 22nd, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, UK|Tags: , , , , , |

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 [...]

UK: MHRA updates regulatory status of equipment being used to help prevent coronavirus (COVID-19)

2024-02-29T16:29:24+00:00May 20th, 2020|Categories: Compliance, Covid-19, UK|Tags: , , , |

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 [...]

MHRA regulatory flexibilities resulting from the COVID-19

2024-02-29T13:49:11+00:00May 8th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, UK|Tags: , , , , , |

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 [...]

Go to Top