GCP inspection statements documenting serious breaches in 2018
Till Bruckner made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency
This request has been closed to new correspondence. Contact us if you think it should be reopened.
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.
Thank you for your time, best wishes,
Thank you for your email. This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team
Please note that we are currently experiencing an unusually high number of
queries due to Covid-19, which may mean that it takes slightly longer for
us to respond than usual, please bear with us.
For information on how MHRA is responding to Covid-19, please visit our
You can expect a reply from us within a few days for a straightforward
request. Where a more detailed response or contribution from a specialist
is required this is likely to take longer but we will inform you of this.
If your request is urgent, please call us on 020 3080 6000
Our opening hours are Mon – Fri 9am to 5pm (excluding UK Public Holidays)
Medicines and Healthcare products Regulatory Agency
10 South Colonnade,
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
If you have a query about this letter, please do not hesitate to contact
us at 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
The Information Commissioner’s Office
They will make a decision on whether or not we have interpreted the FOIA
correctly in handling your request.
IE&S FOI Team
Inspection, Enforcement and Standards
We work to defend the right to FOI for everyone
Help us protect your right to hold public authorities to account. Donate and support our work.Donate Now