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Press statement
| Date: | 07 Dec 2006 |
|---|---|
| Time: | 12:30 |
| Subject: | EWG Clinical Trial Report |
| Contact: | Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189 |
Professor Kent Woods, Chief Executive of the MHRA said, “We welcome today’s report, produced through wide consultation by independent experts. The MHRA has already implemented nationally the recommendations outlined in the report that affect the Agency’s procedures for authorising trials. Some recommendations will need to be taken forward at EU level and the Agency has already started discussions with other European regulators to take these forward as a priority.
“Clinical trials in general have an excellent safety record, but it is important that we learn the lessons from the TGN1412 incident to optimise the safety of future phase 1 studies, particularly those involving these novel medicines.”
The final report on Phase 1 Clinical Trials by the independent Expert Working Group can be viewed on the Department of Health website:
›
Expert Group on Phase One Clinical Trials: Final report (external link).
Notes to Editor
Medicines and Healthcare products Regulatory Agency (MHRA) response to final report by independent expert working group on phase 1 clinical trials 
