The History of UKSI 1031
The UKSI 1031 was drawn up by the MHRA and came into force on 1st May 2004.
Since then the UK has enjoyed a legal framework which requires compliance with the Principles of Good Clinical Practice.
As time passed two things became apparent:
Within the UKSI 1031 there were a number of very small errors that would be better corrected and there were things that the MHRA wished to add to UKSI 1031.
Therefore two years after UKSI No 1031 came into force the MHRA issued amending regulations with Statutory Instrument 2006 No.1928, The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006. This Statutory Instrument was laid before Parliament on 20th July 2006 and came into force on 29th August 2006.
