EMA Outlines GCP Inspection Plan for 2017

Regulatory News

The European Medicines Agency (EMA) on Tuesday released its 2017 work plan for good clinical practice (GCP) inspections, which involves collaborating with the US Food and Drug Administration (FDA) to limit duplicative inspections.

Among other expectations for the coming year, the EMA’s GCP Inspectors Working Group will develop new and revised guidelines on the redaction of inspection reports to protect personal data and commercially confidential information, as well as collaborations with member states on other inspections, both of which align with the implementation of the new Clinical Trials Regulation.

Revisions on GCP guidelines for advanced therapy medicinal products and recommendations on the qualifications of inspectors verifying trial compliance with GCPs will be finalized in 2017.

EMA says the following objectives will drive its agenda in the coming year:

• to define in advance the number of GCP inspections to be requested in 2017
• to ensure a broad coverage of product types, therapeutic areas/indications, target populations, sponsors/contract research organizations (CROs)/vendors, studies and sites
• to proactively select the focus areas on indications, populations, geographical locations of sites, recruitment rates, size of sponsors, size of CROs and tasks and other general trends
• to ensure that diverse geographical regions are selected for inspection, including countries outside the EU from which a substantial amount of clinical trial data derives
• to ensure that GCP inspector’s resources are allocated for the conduct of routine and “for cause” GCP inspections in the context of the centralized procedure

“In order to save resources, duplication of inspections should be avoided and increased inspection coverage will be ensured for MAA submitted to both, the Agency and the US FDA,” the work plan says.

Back in 2009, EMA and FDA launched its GCP initiative, which has expanded to include Japan’s Pharmaceuticals and Medical Devices Agency, which will continue in 2017 alongside the more recently established joint EMA-FDA generic drug application inspections initiative from 2013.

EMA will also look to assist other countries in the development of GCP inspection roles, including Albania, the former Yugoslav Republic of Macedonia, Montenegro, Serbia, Turkey, Bosnia and Herzegovina and Kosovo.

Work plan for GCP Inspectors Working Group for 2017