WHO Director-General, Dr Tedros Ghebreyesus declared that the outbreak of COVID-19 caused by the 2019 novel coronavirus (SARS-CoV-2) constitutes a Public Health Emergency of International Concern. Since then many countries have implemented measures to combat the spread of the disease, including restrictions on travel and social interactions. Likewise, WHO HQ in Geneva implemented teleworking for the majority of staff, as of 15 March 2020. In addition, a small group of key WHO staff and experts, including some who work for WHO prequalification Unit (PQT) are involved in activities to combat the COVID-19 pandemic.
Some delays in prequalification activities are likely to occur since:
- Inspections must be suspended or postponed if:
- Manufacturing sites to be inspected are in one of the outbreak hotspots or where travel has been restricted.
- Manufacturing sites themselves have cancelled planned inspection following their own restrictions forbidding entry of visitors into their premises, or if their staff are quarantined at home.
- Co-inspectors are not allowed to travel given restrictions imposed by their institutions and/or National Regulatory Authorities.
- Some PQT staff and experts are now dedicating time to COVID-19 activities such as the Emergency Use Listing (EUL) for IVDs and providing expert input on possible therapeutics and vaccines.
- Applicants may be unable to respond to PQ assessment questions and inspection observations in a timely manner due to movement and work restrictions at their sites. PQT is already receiving requests for more time as a result of these restrictions and these are granted on case-by-case basis.
PQT and WHO in general are seeking to mitigate the impact of the COVID-19 on delivery of mandates, including through:
- Increased GMP/QMS desk assessment of manufacturing sites, where appropriate.
- Expansion of consultant pool to boost PQT’s surge capacity.
- Increased medicines assessment via external assessors.
- Prioritization of products based on public health needs.
- Enhanced teleworking capacity and tools.
We are working hard to minimize the impact of COVID-19 but request your patience and understanding.
Deusdedit Mubangizi
Head, Prequalification Unit