Update on the EMA Guidance for Applicants/MAHs involved in GCP Inspections

The EMA published the revised Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA, Version 3.1. By this revision only the GCP section of the document has been amended. Previous revisions included the following additions: 

Correction on the documentation to be provided in GCP Inspections

On the one hand, the requirements for GCP inspections were revised with regard to the documentation of the study centers, which must be submitted via the IRIS portal no later than 10 days after notification of an inspection. The following has been added:

  • A written statement is required 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".

On the other hand, it has been emphasized that the documentation listed in the guide, which is to be made available to the inspectors, should be transmitted or handed over exclusively to the GCP inspectors and only after consultation (i.e., the reporting inspector should be contacted to discuss these requirements prior to submitting any documents). The following has been added:

  • Ensure that documents are separate files and with meaningful filenames and send the information to each of the inspector(s) listed by a date agreed with the reporting inspector. Liaise on this topic directly with the reporting inspector as soon as possible. Documents containing text should be searchable files and scanned copies are not acceptable for documents that already exist in electronic format. For documents maintained in paper, e.g. the delegation log or trial participant screening/enrolment log, scanned copies are acceptable.

More information is available in EMA´s Guidance for applicants / MAHs involved in GMP, GCP and GVP inspections published on EMA´s GCP website.

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