The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have implemented two changes to the UK amendment process for clinical trials from 25 March 2021. Read more “Key changes to UK amendment process for clinical trials”
Category: MHRA
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency
Detailed guidance on the Target Development Profile Toolkit
When the Innovative Licensing and Access Pathway (ILAP) was launched at the start of 2021, it was announced that the Target Development Profile (TDP) will be available to applicants to support their application through this pathway. Read more “Detailed guidance on the Target Development Profile Toolkit”
MHRA advice on responding to GLP and GCP inspection reports
The Medicines and Healthcare products Regulatory Authority (MHRA) has released guidance for industry on preparing responses to good laboratory practice (GLP) and good clinical practice (GCP) inspection reports. Read more “MHRA advice on responding to GLP and GCP inspection reports”
The future of UK clinical research delivery
The United Kingdom (UK) government has released a policy paper detailing its vision for the future of clinical research in the UK. Read more “The future of UK clinical research delivery”
MHRA pilots patient involvement in new medicines applications
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the launch of a pilot project aimed at ensuring patient involvement in clinical trials and medicines development. Read more “MHRA pilots patient involvement in new medicines applications”
On-site GxP inspections to resume in the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a resumption of their on-site GxP inspection activities from 29 March 2021. Read more “On-site GxP inspections to resume in the UK”
Latest guidance on the importing of medicines and devices into Northern Ireland after Brexit
A combination of newly released and recently updated guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) clarifies the requirements and procedures for the importing of medicines and devices into Northern Ireland (NI) following the end of the transition period. Read more “Latest guidance on the importing of medicines and devices into Northern Ireland after Brexit”
ACCESS Consortium guidance on updating authorised coronavirus vaccines in the wake of virus mutations
The regulatory approval of COVID-19 vaccines towards the end of 2020 and start of 2021 coincided with the detection of new SARS-CoV2 strains in the UK, South Africa and Brazil. The ACCESS consortium has released a document detailing the regulatory approach for updating authorised coronavirus vaccines to target new strains. Read more “ACCESS Consortium guidance on updating authorised coronavirus vaccines in the wake of virus mutations”
What is the Safer Medicines in Pregnancy and Breastfeeding Information Consortium?
This network is formed of 16 organisations from the National Health Service (NHS), regulators, and leading third sector and charitable organisations. The aim of the consortium is to improve the dissemination of information for women who are considering pregnancy, are already pregnant or are breastfeeding. Read more “What is the Safer Medicines in Pregnancy and Breastfeeding Information Consortium?”
MHRA updates numerous procedural guidance documents
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated several procedural guidance documents with more detailed information relating to application processes. The changes are summarised below. Read more “MHRA updates numerous procedural guidance documents”