Europe: New Guidance for Applicants/MAHs Involved in GMP & GCP Inspections Coordinated by EMA

GMP Inspections

• Contact details of the persons in the inspection services who will be involved can be found in the IRIS Industry portal. Applicants / MAHs need to inform if any information given has changed or is incorrect and if there are any problems with the proposed timing.
• Inspection fees: In addition to the fees, the applicant / MAH is required to meet the travel and accommodation costs of the inspector(s) (and, if present, the expert), for sites located outside the EU/EEA. These expenses are to be paid directly by the applicant/MAH to the inspectors’ authorities and according to the policy/requirements of the inspectors’ authorities which may vary amongst the Member States.
  • Via the IRIS Industry portal, a purchase order (PO) reference number within 10 working days of inspection announcement is requested.

GCP Inspections

• Details of each of the inspections adopted by the Committee, including the names and addresses of the investigational facilities to be inspected and the inspection services that will be involved can be found in the IRIS Industry portal.
• The applicant/MAH) and each inspection selected site must provide the EMA and inspectors with a written statement via the IRIS Industry portal.
  • This statement should include that the sites selected for inspection accept to be inspected and that they will make available all documents required, including medical records/source data at the investigator sites, for direct access by the EU/EEA inspectors.
  • This written statement needs to be provided prior to the departure of the inspection team to the inspection.
  • Without this written statement, the inspection may not proceed.
  • Restricting or obstructing the inspectors’ access to information (data, documents, systems and/or, facilities) may provide grounds for non-acceptance of the trial data.
• Site(s) need to be advised that as of the day of the announcement, for ongoing trials, IMP should no longer be returned from the site to the sponsor or sponsor’s subcontracted CRO or destroyed.
• Fees – as above with GMP inspections
• Provide the following documents and information via the IRIS Industry portal within 10 working days of the notification of the inspection(s) or otherwise as agreed with the Reporting Inspector:
  • Written statement from the applicant/MAH, and each site that is selected for inspection (e.g. the principal investigator for a clinical site), containing the following statement which should be signed and attached as a scanned copy if wet ink signed: “The site(s) accept to be inspected and to make available all documents required, including medical records/source data at the selected investigator site(s), for direct access by the inspectors”.
  • Contact names for the inspection, full addresses, telephone, and email addresses for sites to be inspected.
  • A written statement confirming whether the applicant/MAH of this marketing authorisation application is the sponsor of the trial in question.
  • A written statement confirming that the trial participants enrolled/screened in the trial signed an informed consent stating that EU/EEA regulatory authority(ies) will be granted direct access to the trial participants’ original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the trial participant, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the trial participant or the trial participant's legally acceptable representative is authorizing such access.
  • A purchase order (PO) reference number.

Pages 3 to 6 list 36 documents (see attachment below) for the inspection team, which must only be provided to the inspectors (the reporting inspector should be contacted to discuss these requirements prior to submitting any documents).

If interim data has been submitted in support of the application, measures should be put in place ensuring that the unblinded data are made available to the inspectors but still remain blinded as appropriate for the trial staff, when providing documents at any stage of the inspection.

Any responses to a LoQ or LoOI in relation to the inspection must be addressed by the applicant to the inspection team in addition to the Rapporteur/Co-rapporteur, CHMP, EMA Product Leader (PL) and EMA Inspection Coordinator.

The document is available here.