Joiners and leavers Those of you that have contacted the Defective Medicines Report Centre (DMRC) recently may have encountered some new names – I started as manager of the DMRC team in early April, joining Christine Cox and Alison Bunce. Also …
We've had a number of instances where licensed versions of commonly supplied unlicensed medicines have become available. We want to remind stakeholders what to do if this happens. Recent examples of newly licensed products of this nature include fomicyt, 40mg/ml fosfomycin …
I am pleased to share the news that the UK Good Laboratory Practice Monitoring Authority's (UK GLPMA) guidance on the implementation and maintenance of a risk-based GLP quality assurance (QA) programme has been published. The GLPMA have for some time recognised there …
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 …
MHRA has now published 7 case studies highlighting the work of our Innovation Office and showing how we help organisations that are developing innovative medicines, medical devices or using novel manufacturing processes to effectively navigate regulatory processes, so they can progress their products …
The launch of the new integrated British Pharmacopoeia website this week presents a great opportunity to explore this other group within the Inspection, Enforcement & Standards Division of MHRA. The British Pharmacopoeia (BP) makes an important contribution to the role of MHRA …
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 …
