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.
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