On 30 January 2020, WHO Director-General, Dr Tedros Ghebreyesus declared that the outbreak of COVID-19 caused by the 2019 novel coronavirus (SARS-CoV-2) had constituted a Public Health Emergency of International Concern. Since then various measures have been implemented by countries to combat the spread of the disease which have forced many manufacturers of active pharmaceutical ingredients (APIs), finished pharmaceutical products (FPPs), vaccines, medical devices including in-vitro diagnostics (IVDs), vector control products, quality control laboratories and contract research organizations (CROs) of WHO Prequalified Products to operate under business continuity mode, impacting the standard way of working, with in some cases, public health needs requiring quick action or re-prioritisation of operations.
As a result, the WHO Prequalification Unit - Inspections Team has received numerous questions on regulatory expectations and flexibility during the COVID-19 pandemic. To assist Stakeholders, a Question and Answer document has been prepared by Inspections which will be updated periodically to address new questions and to include further information for organizations to the evolution of the pandemic. It will remain valid until further notice.