News and important information about clinical trials in the UK.
October 2011: Guidance on risk-proportionate approaches to the management and monitoring of clinical trials has now been included in Appendix 2 of the MRC/DH/MHRA Joint Project document "Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products". Please refer to our pages on submitting a notification for a trial for more information.
March 2011: The EU Clinical Trials Register was launched. For further information please visit the EU Clinical Trials Register website (external link).
April 2011: MHRA launched the Notification Scheme. Please refer to the Notification Scheme web pages for details of the types of applications that can be submitted under the Notification Scheme and the requirements for submission.
February 2011: Public consultation on a concept paper on the revision of the 'Clinical Trials Directive'
Following the European Commission public consultation to assess the functioning of the ‘Clinical Trials Directive’ (2001/20/EC) (external link) held from 9 October 2009 to 8 January 2010, a concept paper has been released for consultation to assess the impact of a legislative proposal to revise the Directive.
A copy of the document can be found below:
Revision of the 'Clinical Trials Directive' 2001/20/EC (external link)
June 2010: New eSUSAR website supports electronic reporting of SUSARs by non-commercial sponsors (and SMEs)
The MHRA is currently updating the requirements for submission of SUSAR reports. This includes replacement of CIOMS forms with a new eSUSAR reporting facility (external link). With immediate effect, all UK relevant SUSAR reports should be submitted to the MHRA electronically. A three month transition period will run, during which non-electronic reporting methods will continue to operate.
On 1 September 2010, all non-electronic methods of SUSAR reporting will be turned off and non-electronic reports will no longer be accepted.
Sponsors are encouraged to report electronically as soon as possible, as non-electronic routes do not conform to the ICH E2B standard and, consequently, are sub-optimal.
For more information on electronic reporting and the update to the SUSAR reporting requirements, go to our ‘Safety reporting –SUSARs and ASRs’ page:
Safety reporting –SUSARs and ASRs
April 2010: European Commission updates
On 30th March 2010 the European Commission published a number of documents relating to clinical trials. These include:
- a summary of the responses to their recent consultation on the fuctioning of the Directive (see below)
- new guidance on the request to the Competent Authority for authorisation of a CTA
- updated Q&A
- updated guidance on the conduct of GCP inspections (record keeping and archiving).
These documents are available on the Commission’s website (external link)
February 2010: European Commission review of the Clinical Trials Directive
Between 9 October 2009 and 8 January 2010, the Commission ran a public consultation to assess the functioning of the ‘Clinical Trials Directive’ (2001/20/EC) (external link) seeking comments and responses to a range of questions. A copy of the document can be found below.
The MHRA coordinated a UK Government position on the document and on the specific questions posed by the Commission. To ensure that in coming to a UK position we took account of the views of all those operating in the field governed by the current Directive, we also asked to receive comments from stakeholders. We received 28 responses, which have been incorporated into our final reply to the Commission, published below.
UK Response to the Commission’s consultation
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In February 2010, the European Commission published the public responses to the consultation paper on its website:
Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC (external link)
The Commission will now evaluate the responses that it has received before considering any changes that should be made to the Directive. We would expect there to be first discussions on any proposed changes by Spring 2010.
February 2010: The MHRA is changing bank accounts
As a government organisation, the MHRA has always banked with the Bank of England through the Office of HM Paymaster General (OPG).
In May 2009, the Government Banking Service (GBS), the organisation set up by HM Treasury to provide banking services for public sector customers, informed the Agency that it would be changing the MHRA’s main provider of banking transaction services from the Bank of England to Citi and Royal Bank of Scotland Group (RBSG) before the end of April 2010.
Please note these new bank details for MHRA From 22 February 2010 all sterling and other foreign currency payments should now go to:
Account name: GBS Re MHRA
Account number: 12314800
Sort code: 08-33-00
Swift code: CITIGB2L
Iban: GB05CITI08330012314800
Branch address:
Citibank N.A.
London Branch
Canary Wharf
London
E14 5LB
Please note that proof of payment should be included in your CTA application submission. This should be clearly stated in the covering letter and/or as a separate document (eg photocopy of cheque / confirmation of bank transfer).
