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> 27th June 2008
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Press Release
27th June 2008
Simbec Research Awarded MHRA Supplementary Accreditation
Simbec Research Ltd is among the first group of Phase 1 units in the UK to pass the Medicine Healthcare Regulatory Agency (MHRA) inspection for Standard and Supplementary Accreditation. This means Simbec is approved for the conduct of trials of all types of Investigational Medicinal Products (IMP) including those that need review by the MHRA Expert Advisory Group (EAG). Most IMPs don't need review by EAG, but it's reassuring for all our Sponsors to know that Simbec has been accredited to carry out all types of trials.
Dr Trevor Tanner, Simbec's Scientific Director said "Simbec Research are delighted to be among the first units to be inspected and awarded accreditation. The UK has always been the country of choice for exploratory clinical pharmacology studies and this scheme now sets international standards for early phase clinical trials. The scheme demonstrates the progressive approach of the MHRA which will provide both reassurance to trial participants and confidence to Sponsors"
"Although the scheme is currently a voluntary process it will become increasingly difficult for Sponsors to justify the use of centres that do not have the appropriate level of accreditation".
Since the 2006 TGN-1412 incident, UK regulators have put steps in place to ensure this incident is not repeated, and a new UK regulatory process for "higher risk" compounds has been introduced. This includes a review process involving the EAG and the Commission on Human Medicines (CHM), in addition to the MHRA and Ethics Committees.
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