By Bart Cobert
As everyone who deals with the EU and the UK in drug safety knows, the EMA issued a new set of Good PV Guidelines to replace (largely) Volume 9A. These are more than “guidelines” in the US sense where guidelines represent FDAs current thoughts on the matters addressed but are not binding. In the EU, these guidelines are binding.
For the past several years the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has been using a document called the Summary of Pharmacovigilance Systems (SPS or SPVS).