MHRA

Brexit-and-Medical-Devices-in-the-UK

Brexit and Medical Devices Regulation in the United Kingdom

On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on how medical devices will be regulated in the UK from 01 January 2021, following the UK departure from the European Union.

What does this …

COVID-19-impact-on-Pharmaceutical-Manufacturing

Impact of COVID-19 on Pharmaceutical Manufacturing

How is the pharmaceutical manufacturing industry around the world expected to continue production during the COVID-19 pandemic? What control measures should be in place to help prevent or mitigate the potential adverse effects of COVID-19 on the safety and …

MHRA GMP deficiency data trending 2015

2015 MHRA GMP Inspection Deficiency Data Trends

The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

It is the equivalent …

data measurements

MHRA: Data Integrity defined?

In July 2016, the MHRA released a draft document for consultation entitled MHRA GxP Data Integrity Definitions and Guidance for Industry.  As the name suggests, it is a glossary of DI terms where the definitions are further explained with …

Brexit impact on the MHRA?

Brexit impact on the MHRA?

Brexit causes questions to arise as to the future of the EMA, located in Canary Wharf, London and also about MHRA’s continued contribution to the regulatory control of drugs in the European Union (EU) following the recent Brexit, referendum …