EMA publishes 2020 / 2021 GCP Annual Reports

Recommendation

4-6 June 2024
Munich, Germany

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Following the delayed 2019 Annual Report of the Good Clinical Practice Inspectors’ Working Group (GCP IWG) published earlier this year, the EMA released the 2020 and 2021 annual reports. The delay in the publication of the 2020 report is due to the Agency’s Business Continuity Plan and prioritisation of activities for the COVID-19 pandemic.

Annual Report for 2020

In 2020, seven CHMP requested GCP inspections were conducted remotely, and three inspections were conducted in a hybrid setting (part on-site, part remotely). A total of 363 deficiencies, comprising 16 critical, 200 major and 147 minor findings were recorded for the 34 CHMP requested inspections conducted in 2020. The majority of findings was related to "Trial Management" (e. g. Monitoring, Data Management, Document Control, CSR, Audit) followed by "General" (e. g. Source Documentation, Qualification/Training, SOPs, Contracts/Agreements) and "IMPs" (e. g. Manufacturing/ Packaging/ Labelling). In addition, the GCP IWG published the following Q&As:

• Q&A 13, which provides guidance on the requirements for principal investigator review and sign-off of data.
• Q&A 14, which provides guidance on whether the sponsor of a clinical trial has the right to audit the manufacturer of the IMP even if the manufacturer has been subcontracted by a CRO involved in the clinical trial.

Annual Report for 2021

In 2021, three CHMP requested GCP inspections were conducted entirely remotely, and three inspections were conducted in a hybrid setting. A total of 286 deficiencies, comprising 24 critical, 152 major and 110 minor findings were recorded for the 27 CHMP requested inspections conducted in 2021. This represents an average of 10-11 findings per site inspected. The three top categories were: "General", "Trial Management" and "Computer System". An increase in findings related to computer systems (e. g. Audit Trail and Authorized Access, Computer Validation, Physical Security System and Backup) is noted compared to the last reports.

In addition, the GCP IWG published the following Q&As:

• Q&A 15, which provides guidance on whether GCP inspectors from regulatory authorities of an EU/EEA Member State have the authority to inspect trial participants’ medical records and other data.
• Q&A 16, which provides guidance on whether the monitoring of bioequivalence clinical trials is mandatory.

More information is available at EMA´s Good Clinical Practice Inspectors Working Group website.