Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer.  We endeavour to
respond to requests within the Department of Health’s target response time
of 18 working days; or 20 working days if your request is a Freedom of
Information request; one month if you are making a request for access to
your personal data under the General Data Protection Regulation 2018.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:

[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [8][MHRA request email]
Stay connected: [9]mhra.gov.uk/stayconnected
 
Please note this is an automated reply; please do not respond to this
message.
 
 
 

show quoted sections

Our Ref: FOI 19/014

Dear Till Bruckner,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 8 January 2019.

I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

show quoted sections

Dear Dr Bruckner

Thank you for your email of 8 January 2019 requesting information on MHRA
updates of clinical trial statuses on EudraCT.

Please find responses to your questions below:

1. Has the MHRA conducted a review of end-of-trial notifications received
in the past to identify all cases in which trials are currently falsely
listed as "ongoing" on EudraCT despite MHRA having received an end of
trial notification?

We can confirm that we have conducted such a review. Unfortunately, due to
historic resource issues, a backlog exists that we are currently working
through.

2. Is MHRA working to update the status of completed UK trials listed
falsely as "ongoing" on EudraCT

Yes; we have a plan in place and we have recently recruited an
administrator who has been tasked with this work. 

3. What steps has MHRA taken to ensure that in future, end of trial
notifications received will be consistently processed and EudraCT status
updates made?

Moving forward, in parallel with managing the backlog, our process will
involve the MHRA Clinical Trials Unit updating EudraCT on a weekly basis
with those end-of-trial notifications received during that week. In the
longer term, the UK government has confirmed that the UK will align with
the new EU Clinical Trials Regulation which will provide further
transparency on the status of the trial. Under these regulations, the
start of the clinical trial, the end of the recruitment of subjects for
the clinical trial and the end of the clinical trial (in that Member
State, in all Member States, and in all third countries) will be notified
by the sponsor directly in the IT system.

If you are dissatisfied with the handling of your request, you have the
right to ask for an internal review. Internal review requests should be
submitted within two months of the date of receipt of the response to your
original email, and can be made by response to this email address. Please
remember to quote the reference number above in any future communications.

If you are not content with the outcome of the internal review, you have
the right to apply directly to the Information Commissioner for a
decision. The Information Commissioner can be contacted at: Information
Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9
5AF.

Yours Sincerely,

Customer Services

Communications division

Medicines and Healthcare products Regulatory Agency

151 Buckingham Palace Road, London, SW1W 9SZ

Telephone: 020 3080 6000

show quoted sections