14-16 June 2023
A working group within the International Coalition of Medicines Regulatory Authorities (ICMRA) has published a report entitled "Reflections on the regulatory Experience of remote Approaches to GCP and GMP regulatory Oversight during the COVID-19 Pandemic".
ICMRA is a voluntary association of drug regulatory authorities from around the world, with the aim of providing strategic coordination, advocacy and leadership. ICMRA acts as a forum to support international cooperation between medicines regulatory authorities. In addition to many national authorities, the EMA is also a member of ICMRA.
The working group entitled "Covid-19 Working Group: Remote GCP and GMP Regulatory Oversight Inspections" has focused on the transition from GCP and GMP inspections to remote inspections during the pandemic. The working group was chaired by the UK MHRA and included representatives from the US FDA, EMA, Health Canada, Swiss-medic, HPRA Ireland, AEMPS Spain, ANSM France, PEI Germany, MHLW/PMDA Japan, TGA Australia, ANVISA Brazil, HSA Singapore, WHO and Saudi FDA. The group met regularly to share their approaches and experiences.
It became apparent that there were different approaches in terms of terminology alone, such as "remote evaluation," "remote assessment," "remote inspections," "desktop inspection," and "distant assessment". Of interest are the risk management processes and hybrid approaches considered, including experiences with different types of digital tools, such as visual technology. These considerations can also provide valuable guidance to the pharmaceutical industry for their own approaches. Problems, challenges and limitations are also outlined and how these can be addressed.
Although this paper is a reflection paper, the lessons learned provide valuable insight into how regulators handled regulatory surveillance, inspections and assessments during the pandemic.
The ICMRA working group also noted that remote inspections would not replace regular and routine on-site GMP inspection, but that they have enabled many regulators to continue their surveillance programme at all. Some regulators have expressed an interest in continuing to supplement their inspections with remote inspections and/or hybrid approaches in the future, or even to replace an on-site inspection entirely in certain cases by, for example, addressing an urgent concern, supporting an application assessment and approval decision, or reviewing certain corrective/preventive actions.