EMA issues guidance on remote GCP inspections

The EMA has issued guidance on how remote good clinical practice inspections should be carried out during the coronavirus pandemic. In the guidance issued (10 June, 2020) the EMA stressed the importance of inspections to its assessment of marketing authorization applications.

The EMA recognizes that on-site inspections may not be possible due to the ongoing pandemic. It also states that remote inspections should not be considered as a replacement for on-site inspections and that inspection teams, with agreement from the Committee for Medicinal Products for Human Use (CHMP), should make the decision on the appropriateness of using remote inspection on a case-by-case basis while also taking into account existing procedures for GCP inspections and considering the potential limitations of using a remote process.

The guidance covers all phases of remote GCP inspections, with a particular focus on the more challenging aspects, such inspection initiation, feasibility assessment and preparation.

Read more here.