International regulators’ reflections on remote approaches to GCP and GMP regulatory oversight during COVID-19 pandemic
Remote inspections have been useful in maintaining regulatory oversight during the COVID-19 pandemic, but cannot fully replace on-site inspections. A remote approach could, nevertheless, become an important complementary inspection tool for regulatory authorities, also in post pandemic times. The full extent of its use in situations outside of a public health emergency would, however, still need to be defined.
These are the key findings of a review of inspection practices applied by international regulatory authorities during the COVID-19 pandemic to enable remote oversight of good clinical practice (GCP) and good manufacturing practice (GMP). The review was carried out by a working group of the International Coalition of Medicines Regulatory Authorities (ICMRA).
The reflection paper discusses the remote oversight approaches taken in the following areas: sharing of documents, facility tours, review of data and access to the relevant electronic systems and interviewing subject matter experts.
Throughout the pandemic, inspectors have assessed the need for inspections and decided on the regulatory oversight approach on a case-by-case basis. If it was decided that a remote evaluation was not suitable for regulatory compliance activities, inspections were either postponed until conditions allowed for an on-site visit, or a hybrid approach (on-site and remote means combined) was adopted.
Due to restrictions aimed at protecting public health, regulatory authorities effectively used digital technologies, such as video conferencing software and devices, in the remote conduct of inspections, evaluations and assessments of certain activities and sites.
This text was replaced on 17 December 2021 to reflect the correct title of the news announcement.