As a Lead Senior GCP Inspector at the UK Medicines and Healthcare products Regulatory Agency (MHRA), I thought it would be useful to write about the changes to the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline …
The International Council for Harmonisation (ICH) Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH E6(R2) Good Clinical Practice (GCP) guideline. The E6(R3) overarching principles, Annex 1, Glossary and 3 Appendices will replace the current E6(R2). These …
GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder queries which relate to the manufacture, import, labelling, licencing requirements and general handling of Investigational Medicinal Products (IMPs). …
The MHRA is retiring the eSUSAR website in favour for Individual Case Safety Reports (ICSR) Submissions - providing users a more robust, stringent, and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs) from Clinical Trials of Investigational …
From Monday 7 to Friday 11 March 2022, the MHRA will be hosting a week-long series of events as part of the Good Practice Symposia Week. The week will include individual events from GCP, GLP and GPvP Inspectorates. Due to …
In parts one and two of this series, we looked at how we responded to the unprecedented challenges the COVID-19 pandemic and the lessons we have learned. In this final part, we explore the challenges ahead. Remote access to EHRs …
In part one of this series, we explored as an introduction how we initially responded to the Covid-19 pandemic to move faster in the set-up and approval of clinical trials. Now we look at the unprecedented challenges we faced in …
New GMP requirements from 31 January 2022 Monday 31 January 2022 saw the Clinical Trial regulation (CTR) come into force in the European Union, and with it, the Commission guidelines on good manufacturing practice for investigational medicinal products for human …
The Covid-19 pandemic has been a challenging time for all of us and in this three-part blog series, we reflect on what we have learnt and how we move forward to implement those learnings for the benefit of the UK …
The MHRA has launched an 8-week public consultation on proposals for legislative changes for clinical trials. Following the UK’s exit from the European Union, the Medicines and Medical Devices Act allows us the opportunity to update our current legislation in relation …
