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.
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 …
I write this blog post just after returning from the 2023 MHRA GMP Symposium in London. It has been more than two years since we held our last event virtually, and over three years since we were face-to-face for the …
The first hybrid GMDP Symposium was held on 21-22 February 2023. For the first time, we offered delegates the opportunity to either watch the event online from the comfort of their homes or to join us in person in West …
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). …
Several companies have contacted the MHRA regarding cannabis-based products for medicinal use. This blog provides information on what authorisations are required in order to manufacture within this sector of the pharmaceutical industry. For an overview of unlicensed Cannabis-Based Products for …
In March 2020 the MHRA Inspectorate published a blog post in which we announced that until further notice we would only conduct on-site inspections linked to the UK Government’s COVID-19 response or any other potential serious public health risk. In …
There has been much discussion of late between regulators and industry on how we can ensure that patients and the public get new medicines as quickly as possible - all the way from development to regulatory approval - while still …
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 …
This is the second part a two-part blog series on the Compliance Monitor Process which is being piloted by the MHRA from April 2022. As outlined in the first part of this blog, the MHRA is starting a pilot in …
This is the first part of a two-part blog series on the Compliance Monitor process which is being piloted by the MHRA from April 2022. The MHRA has a history of implementing risk-based inspection practices: 2009: The risk-based inspection programme …
