A link to the newly published ICMRA paper, which provides a valuable insight into how global regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections.
As a GCP Inspector at the UK Medicines and Healthcare products Regulatory Agency (MHRA), I thought it would be useful to inform you that Annex 2 of the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline has …
The process for submitting Annual Safety Reports (ASRs) for Clinical Trials of Investigational Medicinal Products (CTIMP) to the MHRA is changing. From 01 June 2024, ASRs such as the Development Safety Update Report (DSUR) will not be considered valid unless …
The world of GPvP is highly regulated, but the 2024 GPvP symposium showcased how regulation, collaboration and innovation can work together to enhance compliance, provide opportunities for better ways of working, and improve patient lives. The Symposium welcomed over five …
Launch of a pilot Single Inspection Program, a global approach to GMP inspections of third country manufacturers. Health Canada, the Therapeutic Goods Administration (TGA) and the Medicines & Healthcare products Regulatory Agency (MHRA), all members of the Pharmaceutical Inspection Co-operation Scheme …
Join this unique one-day Symposium on 28 February 2024 and hear the latest on Good Pharmacovigilance Practice (GPvP) in the UK from MHRA inspectors and regulators. Registration is available on the GPvP Symposium website for in-person attendance in West London …
Amendments to the guidance on the MHRA website stipulating changes to the way updates to a MAH’s PV system should be notified to the MHRA have been published. The changes aim to make administration burden less for both MAHs and …
Following the end of the COVID-19 public health emergency declared by WHO in May 2023[1], on-site GMP and GDP inspections were restarted after being postponed or carried out remotely during the pandemic. A number of postponed inspections still need to …
We are currently recruiting for a Good Clinical Practice (GCP) Inspector and a Good Pharmacovigilance Practice (GPvP) Inspector in Compliance Team 1. We are passionate about reaching a diverse pool of candidates from a variety of backgrounds. In this blog …
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 …
