Advisor 465

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

STOP PRESS – global news continued

MHRA publishes latest GCP inspections metrics In May 2020, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued its annual GCP inspections metrics report for the 12-month period from 1 April 2017 to 31 March 2018. FDA acknowledges the importance of collaboration Anna Abram and Mark Abdoo – both senior FDA personnel – have co-authored an interesting FDA Voice article published on 25 June 2020. They explain their views on the importance of collaboration between regulatory agencies, and focus on the FDA’s interactions with the European Commission and the European Medicines Agency over the past decade. The article – which highlights how history has paved the way for numerous critical collaborations on many scientific and regulatory fronts as part of the FDA’s response to COVID-19 – is a useful read for anyone interested in how and why international agencies partner together. Source:

In future issues of Advisor we will review the agency’s findings for inspections of sponsors and investigator sites. Below we provide a general overview, and look in more detail at the findings for inspections of contract research organisations (CROs). Overview During the latest 12-month metrics period, the MHRA GCP Inspectorate performed 88 GCP inspections, comprising • investigator sites (17) • UK laboratory facilities conducting clinical trial sample analysis (13) • commercial sponsors (12) • non-commercial organisations (12) • Phase I units (9) • CROs (9) • bioequivalence inspections performed outside the UK (6) • inspections requested by the European Medicines Agency (EMA) (9) • a CRO inspection performed outside the UK (1). The total number of inspections is approximately 10% lower than in the previous 12-month period (99), with only the number of inspections of non- commercial organisations showing an increase. There were 11 triggered inspections compared with 26 in the previous 12 months. Triggered inspections

are usually performed as a result of information received by the GCP Inspectorate (eg. in response to a serious breach report or in relation to a centralised marketing authorisation application). In this period, they were described as follows: • two UK inspections of non-commercial sponsors • six non-UK bioequivalence inspections • three EMA-requested inspections. The latest report (released on 11 May 2020) relates only to inspections performed by the MHRA in the UK, and includes those that were both carried out and completed in the 12-month metrics period. Metrics from inspections requested by the EMA are produced by the EMA, and findings from inspections of GCP laboratories and UK-triggered bioequivalence inspections are reported by the GCP/Good Laboratory Practice Inspectorate. Across all key sectors (sponsor, CRO and investigator), the MHRA classifies inspection findings according to the same 42 categories. For sponsors and CROs, key areas leading to notable findings were pharmacovigilance, data integrity and essential documents/record keeping. There were no critical findings reported from CRO inspections and generally fewer findings overall for CROs compared with the previous 12 months. One sponsor had particular difficulty in meeting the pharmacovigilance requirements (as laid out in

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Issue 465, 2020

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