GCP inspection statements documenting serious breaches in 2018
Till Bruckner made this Freedom of Information request to Medicines and Healthcare products Regulatory Agency
Dear Medicines and Healthcare products Regulatory Agency,
this FOI request is being filed on behalf of TranspariMED:
According to MHRA documents, the MHRA issues "GCP inspection statements" at the end of each GCP inspection process:
According to the "Annual Review of MHRA GCP Referrals: 2018", GCP inspections in 2018 detected 76 serious breaches of GCP, and a further 15 breaches whose severity had not been determined at the time:
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.
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.
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.
In light of the increased burden placed on the MHRA due to the ongoing pandemic, please feel free to disregard the 20 working day time frame for responding to this FOI. A response within 40 working days is satisfactory.
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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.
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
22^nd may 2020
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.
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
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.
* 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
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
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IE&S FOI Team
Inspection, Enforcement and Standards
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