This post provides guidance around the urgent supply of unlicensed medicines that have needed to be imported out of hours by UK hospitals.
Good distribution practice
The MHRA’s GXP data integrity guide has been published today.
The focus of the 2017 GDP Symposium was risky business! This year the complimentary themes of Risk Management and Transportation ran throughout the various sessions at the event.
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.
To assist wholesalers to understand areas where significant GDP failures have been observed, the GDP Inspectorate has published the inspection deficiency data for 2016.
Today marks the start of the operational phase of the EU-FDA mutual recognition agreement
The MHRA has seen an increasing number of inspections being conducted in both the UK and the rest of the EU by regulators from other countries.
From 11 to 15 September 2017 I attended the PIC/S Committee meeting, Executive Bureau meeting, and Annual Seminar hosted by the Taiwan Food and Drug Administration (TFDA)
A bite sized summary of our recent posting to the MHRA Inspectorate blog
Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.