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References

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Our Ref: FOI 20/189

Dear Till Bruckner,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 24 April 2020.

I confirm that your request is now 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,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

show quoted sections

22^nd may 2020

Dear Requestor,

REF: FOI 20/189

As requested under the Freedom of Information Act, please see below the
response to your questions:

1. *The total number of serious breaches of GCP detected by the MHRA
during 2018, including a breakdown into breaches by (a) non-commercial and
(b) commercial trial sponsors.

Total: 87

Non-commercial :48

Commercial: 39

2.** The total number of GCP inspections conducted by the MHRA during
2018, including a breakdown of inspections according to type of trial
sponsor: (a) non-commercial and (b) commercial.

Total:  92 GCP Inspections

Non-commercial:  12

Commercial:  9

CROs:  11            

Phase 1/CRUs:  7             

Investigator sites: 19      

GCP Clinical Labs: 17      

Non UK/EMA: 17

Please note:  this is still to be confirmed as the annual metrics is
currently only drafted and not yet quality checked.

PLEASE NOTE:

*  The serious breaches are those reported to us and not findings
identified during inspection.

** The serious breaches annual metrics is by calendar year (January –
December). However, the annual inspection metrics are reported by
financial year (April – March)

commercial1:  - other commercial organisations including CROs, phase I
units etc, are not included in these figures

3. The EudraCT numbers of all trials in which serious breaches were
discovered by the MHRA during 2018.

4. The GCP inspection statements for each of the trials identified in
response to Question 3. If some or all of the released GCP inspection
statements do not include the related EudraCT numbers (e.g. due to
redactions), please include information in your response to Question 3
that enables GCP inspection statements to easily be cross-linked with
EudraCT numbers.

We would like to inform you that we are unable to provide you with the
information requested in questions 2 and 3. Unfortunately, the information
is exempt from release under section 44:

o Section 44 – Prohibitions on disclosure: the release of information is
exempt as its disclosure is prohibited by other legislation. Under
this section information can be withheld where a statutory bar
prohibits disclosure under any rule or enactment, or is deemed
incompatible with a community obligation. Disclosing this information
would not be appropriate because it would directly breach our
obligations of confidentiality under Article 15(2) of Directive
2001/20/EC and, furthermore, would breach article 30(2) of Directive
2005/28/EC, even if the disclosure was made with the consent of the
sponsor and the report redacted.

Article 15(2) constitutes a “statutory bar” for the purposes of section 44
of the Act and this means that any information obtained for regulatory
purposes under Directive 2001/20/EC is a confidential matter between MHRA
and the parties concerned. Since this obligation stems from a community
directive it is exempt from disclosure under the FOIA. As section 44 is an
"absolute" exemption, there is no requirement to consider the balance of
public interest.

If you have a query about this letter, please do not hesitate to contact
us at [1]IE&[email address]

If you are unhappy with our decision, you may ask for it to be reviewed.
That review will be undertaken by a senior member of the Agency who has
not previously been involved in your request. If you wish to pursue that
option please write to the Communications Directorate, Medicines and
Healthcare products Regulatory Agency, 10 South Colonnade, Canary Wharf,
London E14 4PU.

After that, if you remain dissatisfied, you may write to the Information
Commissioner at;

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

They will make a decision on whether or not we have interpreted the FOIA
correctly in handling your request.

Yours sincerely

IE&S FOI Team

MHRA

Inspection, Enforcement and Standards

cc FOI_Policy

show quoted sections