BRIEF—UK medicines regulator releases guide to data integrity practice

UK drugs regulator MHRA - the Medicines and Healthcare products Regulatory Agency - has released updated guidance on GxP data integrity.

The guide is designed to address “fundamental failures” on the part of manufacturers, “many of which have resulted in regulatory action.”

The document will assist drugmakers in understanding how to ensure their approach to data management complies with good laboratory, clinical, manufacturing, distribution and pharmacovigilance practices.