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...

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...

GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder...

GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder...

Several companies have contacted the MHRA regarding cannabis-based products for medicinal use. This blog provides information on what...

Several companies have contacted the MHRA regarding cannabis-based products for medicinal use. This blog provides information on what...

In March 2020 the MHRA Inspectorate published a blog post in which we announced that until further notice we would only conduct on-site...

In March 2020 the MHRA Inspectorate published a blog post in which we announced that until further notice we would only conduct on-site...

New GMP requirements from 31 January 2022 Monday 31 January 2022 saw the Clinical Trial regulation (CTR) come into force in the European...

New GMP requirements from 31 January 2022 Monday 31 January 2022 saw the Clinical Trial regulation (CTR) come into force in the European...

In August 2020 the International Coalition of Medicines Regulatory Authorities (ICMRA) established a working group to look at the move to...

In August 2020 the International Coalition of Medicines Regulatory Authorities (ICMRA) established a working group to look at the move to...

Technical transfer of analytical methods, or analytical method transfer (AMT) is a GMP requirement for those involved in contract...

Technical transfer of analytical methods, or analytical method transfer (AMT) is a GMP requirement for those involved in contract...

As with all areas of the Agency, the start of lockdown this time last year meant a complete change to the way of working for the...

As with all areas of the Agency, the start of lockdown this time last year meant a complete change to the way of working for the...

Investigations are an inevitable aspect of any manufacturer’s or wholesaler’s operations; whilst every company strives to put in place...

Investigations are an inevitable aspect of any manufacturer’s or wholesaler’s operations; whilst every company strives to put in place...

During this period where MHRA has been conducting predominantly remote inspections, we have reflected on some of the common factors in...

During this period where MHRA has been conducting predominantly remote inspections, we have reflected on some of the common factors in...