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 Medicines and Healthcare products Regulatory Agency (MHRA) has embarked on a recent initiative to evaluate the feasibility of conducting stand-alone inspections of pharmacovigilance contract service providers. In July 2003 MHRA introduced a statutory pharmacovigilance inspection programme of marketing authorisation …
The good manufacturing practice (GMP) Inspectorate performs a varied role in ensuring both medicines and bloods are available and are of the right quality using a risk-based inspection programme. A programme for the inspection of manufacturer and wholesale dealer licence …
The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed. This blog highlights …
We have recently had a number of situation where importers of unlicensed medicines have attempted to notify MHRA of centrally authorised products for import as unlicensed medicines. This is not appropriate, as these are not unlicensed medicines and should be distributed …
Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. A robust data governance approach will ensure that data is complete, consistent and accurate, irrespective of the format in which data is …
A highlight of our work is when we get to engage with you through our symposia. It is a rewarding opportunity for us to keep many hundreds of you – our stakeholders - up to date with the latest regulatory …
Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality.
Our inspectors have a direct impact on the safety and quality of the medicines that are taken by thousands of patients every day. We currently have some fantastic career opportunities available to join our team.
A large part of our role in the MHRA inspectorate involves engaging with our stakeholders. Keeping you informed of the latest changes to regulatory thinking and changes in guidance and requirements is crucial in our mission.
