EMA issues guidelines for remote Good Clinical Practice Inspections

On 10 June 2020, the Europeans Medicines Agency (EMA) issued guidance on how remote good clinical practice inspections (GCP) should be carried out during the coronavirus pandemic. The EMA stressed the importance of inspections to its assessment of marketing authorization applications. However, it recognizes that on-site inspections may not be possible due to the ongoing pandemic due to travel restrictions and risks to staff health.

  The EMA therefore recommends 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.

It notes that these remote processes should not be viewed as a replacement for on-site GCP inspections but are a necessary consideration in the current circumstances. The EMA further notes that while standard procedures apply in the case of remote inspection, preparation for them will be more complex and require an assessment of whether the necessary technical requirements can be met to provide remote access. It advises on early engagement with sponsors and sites. The guidance cautions: “Remote inspections require a more customised preparation by the inspectee and the inspection team as compared to on-site inspections.”

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 (EMA website).

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