Last time we looked at the MHRA response (COVID-19 – Regulators Respond – UK Focus), today we shall focus on the USA.
Many aspects of our lives have been affected by the pandemic which has seen cases and deaths around the world.
The pharmaceutical industry has by no means escaped this impact. We have experienced an increase in demand for products used to treat COVID-19 symptoms; the disruption of product supply; an impact on manufacturing, clinical trials and R&D, the curtailment of on-site inspections, problems in meeting timelines and requirements set by regulatory agencies, I could go on…
So far we have looked at how the EU and UK regulatory authorities, the EMA and MHRA, are responding to the COVID-19 pandemic and, specifically, what flexibility they are offering to support the pharmaceutical industry.
Today we shall focus on the USA:
The FDA, under the Emergency Use Authorization authority is prioritizing assessment of any medicines applications related to COVID-19. This is being done on a case-by-case basis.
In March 2020 the FDA temporarily postponed all routine inspections, both domestic and foreign. For pre-approval inspections the FDA is using other methods as part of their inspection strategy for example requesting existing inspection reports from other agencies.
Since July 2020 domestic pre-approval and surveillance inspections are gradually being resumed according to risk-analysis. Additionally, inspections are being carried out following communication with the site, rather than “no-notice” inspections.
Foreign pre-approval and for-cause inspections (not including those for critical products) will remain temporarily postponed, while those for critical products will be considered for inspection on a case-by-case basis.