Good clinical practice
Eighteen months have passed since the MHRA published its GMP data integrity guidance. Since then we have seen pharmaceutical industry make significant effort to implement the guidance globally. It has been encouraging to see industry stakeholders and regulatory partners adopting …
As with most activities in clinical trials, the development of electronic systems is playing an increasing role in methods for data collection. As inspectors we are therefore continually seeing new systems while out and about on inspection, and adapting our …
The Medicines and Healthcare products Regulatory Agency (MHRA) UK is honoured to be the host of the 2016 PIC/S Seminar. This is an annual international event attended by both member and non-member authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). …
A year ago today we launched the MHRA Inspectorate blog. Now, after 12 months of activity it’s a good time to reflect on where we are and what’s to come.
We are aware there is some concern for UK business and personal careers, over the status of transitional QPs that were recognised under the transitional arrangements provided in SI 2004/1031, when the Clinical Trials Directive was implemented in 2004. The …
In October 2015 a number of MHRA GCP Inspectors attended the GCP Inspectors Working Group Workshop hosted by the European Medicines Agency (EMA) in London. This is an annual training event originally held for EU Good Clinical Practice (GCP) Inspectors that …
My name is Balall Naeem and I have been with the MHRA for more than 10 years now. In that time, I have worked across 3 different Divisions in a number of roles. The ones most relevant for this topic would …
We are aware there is some concern for UK business and personal careers, over the status of transitional QPs that were recognised under the transitional arrangements provided in SI 2004/1031, when the Clinical Trials Directive was implemented in 2004. The …
Happy New Year! Having pestered my team for ideas for the blog and articles it seems only fair I start 2016 by writing one myself, with a focus on stakeholder engagement and the new EU Clinical Trials Regulation update. My …
Back in October I attended, with MHRA colleagues, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) committee meeting and annual seminar that was this year hosted by the Indonesian National Agency for Drug and Food Control (NADFC). In the new year I'll …
